Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy

NCT00952848 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000644516MCV-MCC-12110
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

  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)

  15 days

Secondary Outcomes (3)

• Effect of MC5-A on Pain and Neuropathy

  2 weeks

• Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy

  2 weeks

• Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument

  2 weeks

Study Arms (1)

MC5-A Scramble instrument

EXPERIMENTAL

Treatment of chronic neuropathic pain with the MC5-A device

Other: questionnaire administration; Other: Sensory Neuropathy Scale instrument; Other: Quality of Life instrument; Device: MC5-A Scrambler device

Interventions

questionnaire administration OTHER

Pain Rating Score

MC5-A Scramble instrument

Sensory Neuropathy Scale instrument OTHER

ECOG Common Toxicity Criteria for Sensory Neuropathy scale

MC5-A Scramble instrument

Quality of Life instrument OTHER

Uniscale 0-100 scale global quality of life

MC5-A Scramble instrument

MC5-A Scrambler device DEVICE

Electrical stimulation for 60 minutes

MC5-A Scramble instrument

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neurotoxicity Syndromes; Pain; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Results Point of Contact

• Title: Thomas J. Smith, MD, FACP
• Organization: Virginia Commonwealth University

tsmit136@jhmi.edu

410-955-2091

Study Officials

• Thomas J. Smith, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: June 12, 2009
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: March 29, 2017
• Results First Posted: March 22, 2013

Record last verified: 2017-02