Clinical trial NCT00952848: Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Official title: The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapeutic Agent Toxicity
Neurotoxicity
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: pain
neurotoxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific
peripheral neuropathy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: OBJECTIVES:

Primary

* To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.

Secondary

* To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.
* To evaluate the effect of MC5-A therapy on overall quality of life.
* To evaluate the effect of MC5-A therapy on other pain drugs used.
* To evaluate the toxicities of MC5-A therapy.

OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60 minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10 minutes to the maximum intensity individually bearable by the patient without any input of pain or discomfort. The patient should feel the disappearance of the pain during treatment as a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent treatments begin at the highest intensity tolerated at the previous treatment. Patients with no improvement after 3 treatments discontinue treatment.

Patients complete questionnaires about symptoms, pain, and quality of life periodically.

After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3 months, and at 6 months.

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

Primary outcomes:
measure: Change in Pain Score
timeFrame: 15 days
Secondary outcomes:
measure: Effect of MC5-A on Pain and Neuropathy
timeFrame: 2 weeks
measure: Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy
timeFrame: 2 weeks
measure: Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Thomas J. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: