Phase 2
N=18
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Chemotherapeutic Agent Toxicity · Neurotoxicity · Pain · Peripheral Neuropathy · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00952848 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Mar 2013
Primary outcome: Primary: Change in Pain Score — 2.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- questionnaire administration (Other); Sensory Neuropathy Scale instrument (Other); Quality of Life instrument (Other); MC5-A Scrambler device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score |
2.4 | — |
| SECONDARY Effect of MC5-A on Pain and Neuropathy |
1.3 | — |
| SECONDARY Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy |
-41.25 | — |
| SECONDARY Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument |
0.08 | — |
Summary
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.
PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria:
- More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib)
- Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN
- Pain stable for ≥ 2 weeks
- Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible)
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation
- No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed)
- No heart stent or vena cava clips
- No history of epilepsy or brain damage
- No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology [e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.])
- No skin conditions (e.g., open sores) that would prevent proper application of the electrodes
- No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 30 days since prior and no concurrent investigational agents for pain control
- More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment
- No prior or concurrent anti-convulsants
- No concurrent neurotoxic or potentially neurotoxic chemotherapy
- Concurrent pain treatments allowed provided the following criteria are met:
- Pain is not satisfactorily controlled
- Dose of the other medication has been stable for ≥ 4 weeks
Data sourced from ClinicalTrials.gov (NCT00952848). 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.