MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy

NCT01290224 | Completed Phase 2 Results DMC

• 3 other identifiers: MC10C8NCI-2011-0010910-007874
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

  CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.

  On days 1 and 2

Secondary Outcomes (6)

• Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question

  On days 1 and 2

• Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire

  Day 1 and Day 10

• 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

  Week 1 and Week 10

• Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions

  Day 1 and Week 10

• Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  Day 1 to Day 10

Study Arms (1)

Supportive Care

EXPERIMENTAL

See Detailed Description

Other: scrambler therapy; Procedure: sham intervention; Other: questionnaire administration

Interventions

scrambler therapy OTHER

Undergo MC5-A therapy

Also known as: TENPS, transcutaneous electromanipulation by nervous patterns scrambler therapy

Supportive Care

sham intervention PROCEDURE

Undergo sham procedure

Supportive Care

questionnaire administration OTHER

Ancillary studies

Supportive Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Charles L. Loprinzi
• Organization: Mayo Clinic

cloprinzi@mayo.edu

507-284-2511

Study Officials

• Charles Loprinzi, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 5, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-01

Locations

US (1)