Trial Outcomes & Findings for Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy (NCT NCT04367480)
NCT ID: NCT04367480
Last Updated: 2023-09-08
Results Overview
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
6 weeks after the start of intervention
Results posted on
2023-09-08
Participant Flow
7 participants withdrew from the study before randomization to an arm for the following reasons: Became ineligible after registration, Lost to follow-up, Changed their mind.
Participant milestones
| Measure |
Group I (Active TENS)
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Placebo Administration: Wear placebo TENS device
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
Received Intervention and Completed Baseline Assessments
|
72
|
70
|
|
Overall Study
COMPLETED
|
68
|
62
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
| Measure |
Group I (Active TENS)
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Placebo Administration: Wear placebo TENS device
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
App glitch during the study
|
1
|
0
|
|
Overall Study
Device Distribution Error
|
0
|
2
|
|
Overall Study
Ineligible after Randomization
|
0
|
1
|
|
Overall Study
Other Medical Reasons
|
0
|
2
|
Baseline Characteristics
Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Group I (Active TENS)
n=72 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=70 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education level
Less than High School
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education level
High School Graduate
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Education level
College Degree
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Education level
Graduate Degree
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Education level
Chose not to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
|
30 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
32 kg/m^2
STANDARD_DEVIATION 7.9 • n=7 Participants
|
31 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Cancer Type
Breast
|
20 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Cancer Type
GI
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Cancer Type
Hematologic
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cancer Type
Gynecologic
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cancer Type
Other
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Neurotoxic Chemo Class
Platinum
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Neurotoxic Chemo Class
Taxane
|
20 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Neurotoxic Chemo Class
Platinum and Taxane
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Neurotoxic Chemo Class
Bortezomib
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Neurotoxic Chemo Class
Vinca alkaloid
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Time since Neurotoxic Chemo
|
303 days
n=5 Participants
|
667 days
n=7 Participants
|
454 days
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: Participants who completed the baseline assessment were included in the analysis (N=141) except one extreme outlier that was removed from the Active TENS group due to data discordance among similar measures at baseline.
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
Outcome measures
| Measure |
Group I (Active TENS)
n=71 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=70 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
|
32.32 score on a scale
Standard Error 0.57
|
33.37 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: All participants who completed the study were included in the analysis, except one who did not provide Hot/Burning pain data at post-intervention.
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22).
Outcome measures
| Measure |
Group I (Active TENS)
n=67 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=62 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effect of TENS on Hot/Burning Pain
Study Completers
|
1.80 mean of a score on a scale
Standard Error 0.26
|
2.17 mean of a score on a scale
Standard Error 0.27
|
|
Effect of TENS on Hot/Burning Pain
Sample with Baseline >=4
|
3.32 mean of a score on a scale
Standard Error 0.60
|
4.69 mean of a score on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: All participants who completed the study were included in the analysis, except one who did not provide Sharp/Shooting pain data at post-intervention.
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on sharp/shooting pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)
Outcome measures
| Measure |
Group I (Active TENS)
n=67 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=62 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effect of TENS on Sharp/Shooting Pain
Study Completers
|
1.71 mean of a score on a scale
Standard Error 0.25
|
2.04 mean of a score on a scale
Standard Error 0.26
|
|
Effect of TENS on Sharp/Shooting Pain
Sample with Baseline >=4
|
2.87 mean of a score on a scale
Standard Error 0.55
|
4.08 mean of a score on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: All participants who completed the study were included in the analysis, except one who did not provide Numbness data at post-intervention.
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)
Outcome measures
| Measure |
Group I (Active TENS)
n=67 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=62 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effect of TENS on Numbness
Sample with Baseline >=4
|
5.30 mean of a score on a scale
Standard Error 0.26
|
5.57 mean of a score on a scale
Standard Error 0.29
|
|
Effect of TENS on Numbness
Study Completers
|
4.78 mean of a score on a scale
Standard Error 0.27
|
5.30 mean of a score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: All participants who completed the study were included in the analysis, except one who did not provide Tingling pain data at post-intervention.
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)
Outcome measures
| Measure |
Group I (Active TENS)
n=67 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=62 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effect of TENS on Tingling
Study Completers
|
4.32 mean of a score on a scale
Standard Error 0.27
|
4.51 mean of a score on a scale
Standard Error 0.28
|
|
Effect of TENS on Tingling
Sample with Baseline >=4
|
4.86 mean of a score on a scale
Standard Error 0.29
|
5.10 mean of a score on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: 6 weeks after the start of interventionPopulation: All participants who completed the study were included in the analysis, except one who did not provide Cramping pain data at post-intervention.
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)
Outcome measures
| Measure |
Group I (Active TENS)
n=67 Participants
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=62 Participants
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Placebo Administration: Wear placebo TENS device
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effect of TENS on Cramping
Study Completers
|
1.61 mean of a score on a scale
Standard Error 0.24
|
2.25 mean of a score on a scale
Standard Error 0.25
|
|
Effect of TENS on Cramping
Sample with Baseline >=4
|
2.92 mean of a score on a scale
Standard Error 0.58
|
4.27 mean of a score on a scale
Standard Error 0.58
|
Adverse Events
Group I (Active TENS)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 1 deaths
Group II (Placebo TENS)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I (Active TENS)
n=72 participants at risk
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=70 participants at risk
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Placebo Administration: Wear placebo TENS device
|
|---|---|---|
|
General disorders
Disease Progression
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
Other adverse events
| Measure |
Group I (Active TENS)
n=72 participants at risk
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Transcutaneous Electrical Nerve Stimulation: Wear active TENS device
|
Group II (Placebo TENS)
n=70 participants at risk
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Questionnaire Administration: Ancillary studies
Placebo Administration: Wear placebo TENS device
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruising
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.9%
5/72 • Number of events 5 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
2.9%
2/70 • Number of events 2 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Dysesthesia
|
4.2%
3/72 • Number of events 3 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Paresthesia
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
4.3%
3/70 • Number of events 3 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Muscle cramp
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Burning sensation in toes
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/72 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
2/72 • Number of events 3 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
1.4%
1/70 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.4%
1/72 • Number of events 1 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
0.00%
0/70 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
2.8%
2/72 • Number of events 2 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
2.9%
2/70 • Number of events 2 • The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
|
Additional Information
Jennifer Gewandter, PhD
University of Rochester NCORP Research Base
Phone: 585-275-2141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place