MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01290224|
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Pain Peripheral Neuropathy||Other: scrambler therapy Procedure: sham intervention Other: questionnaire administration||Phase 2|
I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Supportive Care
See Detailed Description
Other: scrambler therapy
Undergo MC5-A therapy
Procedure: sham intervention
Undergo sham procedure
Other: questionnaire administration
- 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 [ Time Frame: 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.
- Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question [ Time Frame: 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.
- Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire [ Time Frame: 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 [ Time Frame: 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.
- Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions [ Time Frame: 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.
- Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 [ Time Frame: 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 [ Time Frame: On days 1-11 and for 10 weeks after therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290224
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Charles Loprinzi, M.D.||Mayo Clinic|