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

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

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

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=99 Participants	63.3 years STANDARD_DEVIATION 10.7 • n=107 Participants	62.9 years STANDARD_DEVIATION 9.7 • n=206 Participants
Sex: Female, Male Female	41 Participants n=99 Participants	51 Participants n=107 Participants	92 Participants n=206 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	19 Participants n=107 Participants	50 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=99 Participants	67 Participants n=107 Participants	133 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Race (NIH/OMB) White	60 Participants n=99 Participants	60 Participants n=107 Participants	120 Participants n=206 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Education level Less than High School	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Education level High School Graduate	27 Participants n=99 Participants	26 Participants n=107 Participants	53 Participants n=206 Participants
Education level College Degree	30 Participants n=99 Participants	27 Participants n=107 Participants	57 Participants n=206 Participants
Education level Graduate Degree	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Education level Chose not to answer	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
BMI	30 kg/m^2 STANDARD_DEVIATION 5.8 • n=99 Participants	32 kg/m^2 STANDARD_DEVIATION 7.9 • n=107 Participants	31 kg/m^2 STANDARD_DEVIATION 7.0 • n=206 Participants
Cancer Type Breast	20 Participants n=99 Participants	31 Participants n=107 Participants	51 Participants n=206 Participants
Cancer Type GI	29 Participants n=99 Participants	20 Participants n=107 Participants	49 Participants n=206 Participants
Cancer Type Hematologic	9 Participants n=99 Participants	5 Participants n=107 Participants	14 Participants n=206 Participants
Cancer Type Gynecologic	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Cancer Type Other	7 Participants n=99 Participants	8 Participants n=107 Participants	15 Participants n=206 Participants
Neurotoxic Chemo Class Platinum	31 Participants n=99 Participants	22 Participants n=107 Participants	53 Participants n=206 Participants
Neurotoxic Chemo Class Taxane	20 Participants n=99 Participants	32 Participants n=107 Participants	52 Participants n=206 Participants
Neurotoxic Chemo Class Platinum and Taxane	12 Participants n=99 Participants	11 Participants n=107 Participants	23 Participants n=206 Participants
Neurotoxic Chemo Class Bortezomib	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Neurotoxic Chemo Class Vinca alkaloid	6 Participants n=99 Participants	1 Participants n=107 Participants	7 Participants n=206 Participants
Time since Neurotoxic Chemo	303 days n=99 Participants	667 days n=107 Participants	454 days n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks after the start of intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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 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
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

SECONDARY outcome

Timeframe: 6 weeks after the start of intervention

Population: 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

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 intervention

Population: 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

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

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

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