MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
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
Other: scrambler therapy
Procedure: sham intervention
Other: questionnaire administration
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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|
- Percentage of patients who have at least a 50% reduction (i.e., success) in at least 1 of the first 12 CIPN measurement questions in the pre/post therapy questionnaire [ Time Frame: On days 1 and 2 ] [ Designated as safety issue: No ]
- Intra-patient change of CIPN symptoms between sham procedure and scrambler therapy as measured by each individual question [ Time Frame: On days 1 and 2 ] [ Designated as safety issue: No ]
- Daily changes and percent reduction in each of the 12 CIPN measurement questions in the daily therapy questionnaire [ Time Frame: During the 10 days of recommended scrambler therapy ] [ Designated as safety issue: No ]
- Weekly changes and percent reduction in CIPN symptoms as measured by the North Central Cancer Treatment Group (NCCTG) peripheral neuropathy question [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Changes in CIPN symptom bother as measured by 8 CIPN symptom questions [ Time Frame: For 10 weeks after the scrambler therapy ] [ Designated as safety issue: No ]
- Toxicity (other than CIPN) profile associated with scrambler therapy as measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 [ Time Frame: By day 10 ] [ Designated as safety issue: Yes ]
- Analgesic use in morphine equivalent units over time [ Time Frame: On days 1-11 and for 10 weeks after therapy ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Supportive Care
See Detailed Description
Other: scrambler therapy
Undergo MC5-A therapy
Other Names:Procedure: sham intervention
Undergo sham procedureOther: questionnaire administration
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.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Charles Loprinzi, M.D.||Mayo Clinic|