Trial Outcomes & Findings for Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy (NCT NCT03329131)
NCT ID: NCT03329131
Last Updated: 2024-10-16
Results Overview
A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Change from baseline to 6 months post chemo (up to 14 months)
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
Cryotherapy
Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock
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|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Baseline characteristics by cohort
| Measure |
Cryotherapy
n=12 Participants
Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 months post chemo (up to 14 months)Population: Only 7 of the subjects were evaluable, and not all data from all time points was available due to suspension of research activities during the pandemic
A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Cryotherapy
n=7 Participants
Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock
|
|---|---|
|
Prevention of Peripheral Neuropathy During Taxane Chemotherapy
|
7.28 score on a scale
Interval 0.0 to 29.0
|
PRIMARY outcome
Timeframe: Baseline to 6 months post Cryotherapy (up to 14 months)Population: Only 8 of the subjects were evaluable for adverse events of Grade 3 or higher, and not all data from all time points was available due to suspension of research activities during the pandemic
Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes
Outcome measures
| Measure |
Cryotherapy
n=8 Participants
Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock
|
|---|---|
|
Evaluate Safety of Cryotherapy Use
|
0 Number of Adverse Events
|
Adverse Events
Cryotherapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cryotherapy
n=12 participants at risk
Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
Cryotherapy: An Elasto gel™ frozen (4°C) glove and sock
|
|---|---|
|
Nervous system disorders
Peripheral neuropathy
|
25.0%
3/12 • Number of events 7 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Nervous system disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Skin and subcutaneous tissue disorders
Rash on hands
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
General disorders
Bone pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Skin and subcutaneous tissue disorders
Dry skin on feet
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
General disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Skin and subcutaneous tissue disorders
Nail bed changes
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Gastrointestinal disorders
Rectal bleeding
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
|
Skin and subcutaneous tissue disorders
Nail bed loss
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months)
For this study, all adverse events will be documented starting with the first use of the cold therapy device and ending 30 days after the last dose use of the cold therapy device, regardless of the length of time the device was used.
|
Additional Information
Virginia Kaklamani, MD
University of Texas Health Science Center in San Antonio
Phone: 210-450-3838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place