Pain, Peripheral Neuropathy
Conditions
Brief summary
RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy
Detailed description
PRIMARY OBJECTIVES: I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN). SECONDARY OBJECTIVES: I. To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use. OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.
Interventions
OTHERscrambler therapy
Undergo MC5-A therapy
PROCEDUREsham intervention
Undergo sham procedure
OTHERquestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib); Note: this neurotoxic chemotherapy must have been completed more than 3 months prior to when they enter this trial * Pain or symptoms of peripheral neuropathy in the feet of \>= 1 month (30 days) duration attributed to chemotherapy-induced peripheral neuropathy, for which the patient wants intervention * Participants have to relate that numbness, tingling or pain in their toes/feet was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2 * Life expectancy \>= 3 months (90 days) * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed written consent * No change in scheduled analgesic agents for at least one week
Exclusion criteria
* Pregnant women * CIPN troubles in the lower extremities more proximal to the mid calf * Patients with implantable drug delivery systems, e.g. Medtronic Synchromed * Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices) * Patients with a history of myocardial infarction or ischemic heart disease within the past six months * Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases * Other identified causes of painful lower extremity paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, Acquired Immunodeficiency Syndrome \[AIDS\], monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) * Skin conditions such as open sores that would prevent proper application of the electrodes * Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study * Prior treatment with Calmare MC-5A therapy for any reason or knowledge of application procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire | On days 1 and 2 | CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Day 1 and Day 10 | The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). |
| Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question | Week 1 and Week 10 | The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week. |
| Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | On days 1 and 2 | The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated. |
| Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | Day 1 to Day 10 | CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. |
| Analgesic Use Over Time | On days 1-11 and for 10 weeks after therapy | — |
| Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Day 1 and Week 10 | The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported. |
Countries
United States
Participant flow
Recruitment details
Ten (10) participants were recruited at Mayo Clinic between February 2011 and April 2011. All 10 participants have completed sham procedure (day 1) and proceed to scrambler treatment (day 2 to 11).
Participants by arm
| Arm | Count |
|---|---|
| Sham Procedure + Scrambler Treatment | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Refused Further Treatment | 4 |
Baseline characteristics
| Characteristic | Sham Procedure + Scrambler Treatment |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 9.8 |
| Duration of pain symptoms at baseline <=6 months | 10 participants |
| Duration of pain symptoms at baseline >6 months | 0 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of neurotoxic agents exposed to Multiple Agents | 3 participants |
| Number of neurotoxic agents exposed to Single Agent | 7 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire
CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.
Time frame: On days 1 and 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire | Sham Procedure | 60 Percentage of Participants |
| Sham Procedure + Scrambler Treatment | Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire | Scrambler Therapy | 50 Percentage of Participants |
Comparison: McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.p-value: 0.763McNemar
Secondary
Analgesic Use Over Time
Time frame: On days 1-11 and for 10 weeks after therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Tylenol | 3 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Ibuprofen | 3 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Cymbalta | 1 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Lyrica | 1 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Tramadol | 1 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Gabapentin | 1 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Acetaminophen | 2 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Oxycontin | 1 participants |
| Sham Procedure + Scrambler Treatment | Analgesic Use Over Time | Oxycodone | 1 participants |
Secondary
Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question
The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.
Time frame: On days 1 and 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet RN | -1 units on a scale | Standard Deviation 1.49 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet RN | -0.8 units on a scale | Standard Deviation 1.4 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet RN | -0.8 units on a scale | Standard Deviation 1.32 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet RN | 0 units on a scale | Standard Deviation 1.41 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet at WP24H | -0.7 units on a scale | Standard Deviation 1.25 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet at WP24H | -0.6 units on a scale | Standard Deviation 1.35 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet at WP24H | -0.7 units on a scale | Standard Deviation 0.95 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet at WP24H | 0.1 units on a scale | Standard Deviation 0.74 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet AvgP24H | -0.4 units on a scale | Standard Deviation 0.7 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet AvgP24H | -0.6 units on a scale | Standard Deviation 1.17 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet AvgP24H | -0.1 units on a scale | Standard Deviation 1.45 |
| Sham Procedure + Scrambler Treatment | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet AvgP24H | -0.3 units on a scale | Standard Deviation 1.77 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet AvgP24H | -0.2 units on a scale | Standard Deviation 1.14 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet RN | -0.2 units on a scale | Standard Deviation 1.62 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet at WP24H | -0.2 units on a scale | Standard Deviation 0.42 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet RN | -0.5 units on a scale | Standard Deviation 0.85 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet AvgP24H | -0.8 units on a scale | Standard Deviation 1.32 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Tingling in toes/feet RN | -0.8 units on a scale | Standard Deviation 1.55 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet at WP24H | 0.2 units on a scale | Standard Deviation 1.4 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet RN | 0.1 units on a scale | Standard Deviation 1.6 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Pain in toes/feet AvgP24H | -0.2 units on a scale | Standard Deviation 1.03 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet at WP24H | 0 units on a scale | Standard Deviation 0.94 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness, tingling, or pain in toes/feet AvgP24H | -0.6 units on a scale | Standard Deviation 2.27 |
| Scrambler Therapy (Day 2) | Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | Numbness in toes/feet at WP24H | -0.7 units on a scale | Standard Deviation 0.82 |
Secondary
Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire
The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).
Time frame: Day 1 and Day 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness, tingling, or pain in toes/feet RN | 43.5 percentage of reduction in symptom | Standard Deviation 41.7 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness in toes/feet RN | 46.7 percentage of reduction in symptom | Standard Deviation 36.3 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Tingling in toes/feet RN | 37.8 percentage of reduction in symptom | Standard Deviation 57.7 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Pain in toes/feet RN | 13.4 percentage of reduction in symptom | Standard Deviation 89.3 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness, tingling, or pain in toes/feet at WP24H | 12.8 percentage of reduction in symptom | Standard Deviation 52 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness in toes/feet at WP24H | 40.6 percentage of reduction in symptom | Standard Deviation 37.5 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Tingling in toes/feet at WP24H | 50.6 percentage of reduction in symptom | Standard Deviation 47.6 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Pain in toes/feet at WP24H (Worsen) | -8.3 percentage of reduction in symptom | Standard Deviation 99.1 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness, tingling or pain in toes/feet AvgP24H | 23.5 percentage of reduction in symptom | Standard Deviation 27.9 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Numbness in toes/feet AvgP24H | 45.2 percentage of reduction in symptom | Standard Deviation 32.2 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Tingling in toes/feet AvgP24H | 48.4 percentage of reduction in symptom | Standard Deviation 46.8 |
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | Pain in toes/feet AvgP24H | 26.6 percentage of reduction in symptom | Standard Deviation 70.8 |
Secondary
Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question
The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.
Time frame: Week 1 and Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question | 3.2 percentage of reduction in symptom | Standard Deviation 38.6 |
Secondary
Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions
The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.
Time frame: Day 1 and Week 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Tingling in toes/feet | 42.9 percentage of a scale | Standard Deviation 45 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Numbness in toes/feet | -25.0 percentage of a scale | Standard Deviation 46.3 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Shooting/burning in toes/feet | -10.0 percentage of a scale | Standard Deviation 89.4 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Problems standing/walking | 21.4 percentage of a scale | Standard Deviation 39.3 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Cramps in toes/feet | 50.0 percentage of a scale | Standard Deviation 44.7 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Difficulty walking | 16.7 percentage of a scale | Standard Deviation 25.8 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Difficulty with stairs | 20.0 percentage of a scale | Standard Deviation 27.4 |
| Sham Procedure + Scrambler Treatment | Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | Difficulty using car foot pedals | 20.0 percentage of a scale | Standard Deviation 44.7 |
Secondary
Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
Time frame: Day 1 to Day 10
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sham Procedure + Scrambler Treatment | Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | Grade 1, 2 | 1 participants |
| Sham Procedure + Scrambler Treatment | Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | Grade 3, 4, 5 | 0 participants |