Clinical trial · Interventional
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
NCT00952848CI-TRIAL-00026681completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MC5-A Scrambler device | Device | — | UNRESOLVED |
| Quality of Life instrument | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| Sensory Neuropathy Scale instrument | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MC5-A Scramble instrument
- description
- Treatment of chronic neuropathic pain with the MC5-A device
- interventionNames
- Other: questionnaire administration
- Other: Sensory Neuropathy Scale instrument
- Other: Quality of Life instrument
- Device: MC5-A Scrambler device
Primary outcomes (1)
- measure
- Change in Pain Score
- timeFrame
- 15 days
- description
- Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)
Secondary outcomes (3)
- measure
- Effect of MC5-A on Pain and Neuropathy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.