Phase 2
N=10
MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
Pain · Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01290224 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: 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 — 60; 50 Percentage of Participants — p=0.7630
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- scrambler therapy (Other); sham intervention (Procedure); questionnaire administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
60; 50 | 0.7630 |
| SECONDARY Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question |
-1; -0.2; -0.8; -0.5; -0.8; -0.8 | — |
| SECONDARY Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire |
43.5; 46.7; 37.8; 13.4; 12.8; 40.6 | — |
| 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 |
3.2 | — |
| SECONDARY Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions |
42.9; -25.0; -10.0; 21.4; 50.0; 16.7 | — |
| SECONDARY Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 |
1; 0 | — |
| SECONDARY Analgesic Use Over Time |
3; 3; 1; 1; 1; 1 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01290224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.