Trial Outcomes & Findings for The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL (NCT NCT03873272)
NCT ID: NCT03873272
Last Updated: 2024-10-03
Results Overview
The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Cryotherapy
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cryotherapy
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
2
|
1
|
Baseline Characteristics
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
Baseline characteristics by cohort
| Measure |
Cryotherapy
n=20 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=5 Participants
|
53.5 years
n=7 Participants
|
51.0 years
n=5 Participants
|
53.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Number docetaxel of treatments before baseline
|
5.1 treatments
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.5 treatments
STANDARD_DEVIATION 0.9 • n=7 Participants
|
4.8 treatments
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.1 treatments
STANDARD_DEVIATION 1.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThe primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes.
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline)
|
0.45 Proportion of Patients
Interval 0.23 to 0.68
|
0.59 Proportion of Patients
Interval 0.36 to 0.79
|
0.52 Proportion of Patients
Interval 0.3 to 0.74
|
SECONDARY outcome
Timeframe: Baseline, 12, and 24 weeksPopulation: The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected.
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a subjective method to evaluate CIPN which is performed by a healthcare professional. The patient's peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia and neuralgia will be graded on a scale of 1 to 5 depending on severity with 1 indicating a better outcome.
Outcome measures
| Measure |
Cryotherapy
n=18 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=19 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Change in NCI-CTCAE Grade for CIPN
Week 12 · Stage decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in NCI-CTCAE Grade for CIPN
Week 12 · Stage increased
|
10 Participants
|
8 Participants
|
7 Participants
|
|
Change in NCI-CTCAE Grade for CIPN
Week 12 · Stage stayed the same
|
5 Participants
|
13 Participants
|
10 Participants
|
|
Change in NCI-CTCAE Grade for CIPN
Week 24 · Stage decreased
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Change in NCI-CTCAE Grade for CIPN
Week 24 · Stage increased
|
11 Participants
|
8 Participants
|
7 Participants
|
|
Change in NCI-CTCAE Grade for CIPN
Week 24 · Stage stayed the same
|
6 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected.
The number of participants with a change in cutaneous toxicity and onycholysis will be assessed by a healthcare professional using the National Cancer Institute Common Toxicity Criteria (Version 2), specifically nail changes. Grade 1 includes discoloration, ridging (koilonychia), or pitting of the nails and Grade 2 is partial or complete loss of nail(s) or pain in the nail beds. A higher grade indicates more nail toxicity.
Outcome measures
| Measure |
Cryotherapy
n=14 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=15 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=16 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Change in Nail Toxicity
Week 12 · Staged decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Nail Toxicity
Week 12 · Stage increased
|
10 Participants
|
7 Participants
|
10 Participants
|
|
Change in Nail Toxicity
Week 12 · Stage stayed the same
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Change in Nail Toxicity
Week 24 · Staged decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Nail Toxicity
Week 24 · Stage increased
|
7 Participants
|
7 Participants
|
11 Participants
|
|
Change in Nail Toxicity
Week 24 · Stage stayed the same
|
1 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected.
Comfort with the study intervention will be assessed on a 4-point scale, (0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied) with 3 indicating a better outcome.
Outcome measures
| Measure |
Cryotherapy
n=16 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=16 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Comfort With Intervention Scale Score
Week 12 · Dissatisfied
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Comfort With Intervention Scale Score
Week 12 · Not Satisfied
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Comfort With Intervention Scale Score
Week 12 · Satisfied
|
9 Participants
|
13 Participants
|
12 Participants
|
|
Comfort With Intervention Scale Score
Week 12 · Very Satisfied
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Comfort With Intervention Scale Score
Week 24 · Dissatisfied
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Comfort With Intervention Scale Score
Week 24 · Not Satisfied
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Comfort With Intervention Scale Score
Week 24 · Satisfied
|
5 Participants
|
10 Participants
|
11 Participants
|
|
Comfort With Intervention Scale Score
Week 24 · Very Satisfied
|
2 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksStudy participants will be assessed for development of sensory neurological dysfunction. Vibration perception will be assessed using a tuning fork. Vibration threshold will be tested on the bilateral dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements.
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Vibration Perception and Disappearance Threshold
Week 12: Hand Perception
|
10.95 Seconds
Standard Deviation 7.34
|
7.70 Seconds
Standard Deviation 3.02
|
8.47 Seconds
Standard Deviation 4.72
|
|
Vibration Perception and Disappearance Threshold
Week 12: Foot Perception
|
20.55 Seconds
Standard Deviation 13.13
|
17.16 Seconds
Standard Deviation 12.25
|
13.29 Seconds
Standard Deviation 6.29
|
|
Vibration Perception and Disappearance Threshold
Week 24: Hand Perception
|
9.79 Seconds
Standard Deviation 6.28
|
7.82 Seconds
Standard Deviation 3.61
|
7.61 Seconds
Standard Deviation 2.30
|
|
Vibration Perception and Disappearance Threshold
Week 24: Foot Perception
|
24.38 Seconds
Standard Deviation 18.54
|
20.84 Seconds
Standard Deviation 13.42
|
13.84 Seconds
Standard Deviation 5.56
|
|
Vibration Perception and Disappearance Threshold
Week 12: Hand Disapperance
|
4.43 Seconds
Standard Deviation 3.87
|
3.09 Seconds
Standard Deviation 1.96
|
3.60 Seconds
Standard Deviation 4.02
|
|
Vibration Perception and Disappearance Threshold
Week 12: Foot Disappearance
|
12.12 Seconds
Standard Deviation 9.53
|
11.33 Seconds
Standard Deviation 8.51
|
7.53 Seconds
Standard Deviation 5.54
|
|
Vibration Perception and Disappearance Threshold
Week 24: Hand Disappearance
|
3.33 Seconds
Standard Deviation 3.39
|
3.04 Seconds
Standard Deviation 2.57
|
2.98 Seconds
Standard Deviation 2.23
|
|
Vibration Perception and Disappearance Threshold
Week 24: Foot Disappearance
|
10.52 Seconds
Standard Deviation 6.15
|
12.90 Seconds
Standard Deviation 10.36
|
6.08 Seconds
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected.
Evaluation of other sensory endpoints including touch, pressure and pain will be evaluated using a Neuropen. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the Neuropen on the dominant foot. The spring mechanism is calibrated to exert a force of 40 grams to help identify subjects with loss of pain sensation. Ten points on the foot are tested. If the participant detects pain and pressure on less than 8 points, pain and pressure perception are considered diminished. Perception on 8 points of the foot or greater is considered a better outcome.
Outcome measures
| Measure |
Cryotherapy
n=14 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=18 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=17 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 12: Touch and Pressure · <8 points of the foot
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 12: Touch and Pressure · >=8 points of the foot
|
11 Participants
|
18 Participants
|
13 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 12: Pain · <8 points of the foot
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 12: Pain · >=8 points of the foot
|
14 Participants
|
17 Participants
|
13 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 24: Touch and Pressure · <8 points of the foot
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 24: Touch and Pressure · >=8 points of the foot
|
10 Participants
|
17 Participants
|
17 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 24: Pain · <8 points of the foot
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Subjects Perceived Pain and Pressure Using Neuropen Test
Week 24: Pain · >=8 points of the foot
|
12 Participants
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksThe 'timed get up and go' test is a rapid and widely used clinical performance-based measure of lower extremity function, mobility, and fall risk. Subjects are asked to stand up from a standard chair (seat height between 44 and 47 cm), walk a distance of 3 m (marked on the floor) at a comfortable pace, turn, walk back and sit down. Time will be measured in seconds. Shorter times indicate better performance.
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Average Time to Complete 'Timed Get up and go' Test
Week 12
|
15.48 Seconds
Standard Deviation 7.98
|
12.36 Seconds
Standard Deviation 3.75
|
15.18 Seconds
Standard Deviation 4.54
|
|
Average Time to Complete 'Timed Get up and go' Test
Week 24
|
17.45 Seconds
Standard Deviation 8.03
|
13.93 Seconds
Standard Deviation 3.04
|
14.84 Seconds
Standard Deviation 5.50
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: The numbers analyzed at the each of the respective timepoints and assessments are the number of participants from which the data was collected.
Balance will be assessed using the tandem and unipedal stance test. In this assessment, the subject stands with one foot in front of the other (heel to toe) (30 seconds), then on one leg with: eyes open (60 seconds), eyes closed (30 seconds), and eyes open with head rotation (30 seconds) with arms held comfortably at the side. The test was accepted failure when the stance foot shifted in any way or the nonstance foot touched the ground. Tests are recorded as achieved (yes) or not achieved (no).
Outcome measures
| Measure |
Cryotherapy
n=13 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=19 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=17 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes open · No
|
6 Participants
|
12 Participants
|
11 Participants
|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes open · Yes
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes closed · No
|
13 Participants
|
17 Participants
|
15 Participants
|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes closed · Yes
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes open, rotated · No
|
11 Participants
|
15 Participants
|
14 Participants
|
|
Tandem and Unipedal Stance Test
Week 12: One leg, eyes open, rotated · Yes
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes open · No
|
10 Participants
|
11 Participants
|
11 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes open · Yes
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes closed · No
|
13 Participants
|
16 Participants
|
14 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes closed · Yes
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes open, rotated · No
|
12 Participants
|
14 Participants
|
14 Participants
|
|
Tandem and Unipedal Stance Test
Week 24: One leg, eyes open, rotated · Yes
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksThe number of participants who adhered to the intervention. Adherence is defined as wearing the assigned gloves and socks for greater than or equal to 80% of infusions.
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 Participants
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Adherence to Study Intervention
80% or Above
|
7 Participants
|
16 Participants
|
16 Participants
|
|
Adherence to Study Intervention
Below 80%
|
13 Participants
|
6 Participants
|
5 Participants
|
Adverse Events
Cryotherapy
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Compression Therapy
Serious events: 3 serious events
Other events: 20 other events
Deaths: 2 deaths
Control Arm (Loose Glove/Sock)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cryotherapy
n=20 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
General disorders
Fever
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
Other adverse events
| Measure |
Cryotherapy
n=20 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
|
Compression Therapy
n=22 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
Control Arm (Loose Glove/Sock)
n=21 participants at risk
Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks.
Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.0%
7/20 • Number of events 8 • Up to 24 weeks
|
40.9%
9/22 • Number of events 11 • Up to 24 weeks
|
47.6%
10/21 • Number of events 12 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
3/20 • Number of events 3 • Up to 24 weeks
|
18.2%
4/22 • Number of events 5 • Up to 24 weeks
|
19.0%
4/21 • Number of events 4 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
General disorders
Chills
|
10.0%
2/20 • Number of events 2 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • Up to 24 weeks
|
27.3%
6/22 • Number of events 6 • Up to 24 weeks
|
33.3%
7/21 • Number of events 7 • Up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
8/20 • Number of events 12 • Up to 24 weeks
|
54.5%
12/22 • Number of events 12 • Up to 24 weeks
|
28.6%
6/21 • Number of events 8 • Up to 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • Number of events 4 • Up to 24 weeks
|
36.4%
8/22 • Number of events 8 • Up to 24 weeks
|
28.6%
6/21 • Number of events 7 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • Up to 24 weeks
|
13.6%
3/22 • Number of events 3 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
General disorders
Edema limbs
|
20.0%
4/20 • Number of events 4 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
14.3%
3/21 • Number of events 3 • Up to 24 weeks
|
|
General disorders
Fatigue
|
30.0%
6/20 • Number of events 7 • Up to 24 weeks
|
59.1%
13/22 • Number of events 16 • Up to 24 weeks
|
47.6%
10/21 • Number of events 10 • Up to 24 weeks
|
|
General disorders
Administration site conditions
|
15.0%
3/20 • Number of events 4 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
4/20 • Number of events 4 • Up to 24 weeks
|
22.7%
5/22 • Number of events 5 • Up to 24 weeks
|
28.6%
6/21 • Number of events 6 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Number of events 5 • Up to 24 weeks
|
9.1%
2/22 • Number of events 3 • Up to 24 weeks
|
33.3%
7/21 • Number of events 7 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
25.0%
5/20 • Number of events 5 • Up to 24 weeks
|
27.3%
6/22 • Number of events 6 • Up to 24 weeks
|
47.6%
10/21 • Number of events 10 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
2/20 • Number of events 2 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
14.3%
3/21 • Number of events 4 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Number of events 11 • Up to 24 weeks
|
54.5%
12/22 • Number of events 12 • Up to 24 weeks
|
47.6%
10/21 • Number of events 11 • Up to 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • Number of events 2 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
General disorders
Pain
|
20.0%
4/20 • Number of events 5 • Up to 24 weeks
|
13.6%
3/22 • Number of events 3 • Up to 24 weeks
|
14.3%
3/21 • Number of events 4 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 5 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
3/20 • Number of events 3 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
10.0%
2/20 • Number of events 3 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
20.0%
4/20 • Number of events 4 • Up to 24 weeks
|
18.2%
4/22 • Number of events 5 • Up to 24 weeks
|
19.0%
4/21 • Number of events 5 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
10.0%
2/20 • Number of events 2 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
13.6%
3/22 • Number of events 3 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 2 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
0.00%
0/21 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/20 • Up to 24 weeks
|
9.1%
2/22 • Number of events 2 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
13.6%
3/22 • Number of events 3 • Up to 24 weeks
|
4.8%
1/21 • Number of events 1 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/20 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • Number of events 1 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
14.3%
3/21 • Number of events 3 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
9.5%
2/21 • Number of events 4 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Up to 24 weeks
|
4.5%
1/22 • Number of events 1 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/20 • Up to 24 weeks
|
0.00%
0/22 • Up to 24 weeks
|
9.5%
2/21 • Number of events 2 • Up to 24 weeks
|
Additional Information
Melissa Accordino, MD
Columbia University Irving Medical Center
Phone: 646-317-4692
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place