Clinical trial NCT01290224: MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
Official title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Peripheral Neuropathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: PRIMARY OBJECTIVES:

I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use.

OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: On days 1 and 2
Secondary outcomes:
measure: Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question
timeFrame: On days 1 and 2
measure: Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire
timeFrame: Day 1 and Day 10
measure: 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
timeFrame: Week 1 and Week 10
measure: Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions
timeFrame: Day 1 and Week 10
measure: Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
timeFrame: Day 1 to Day 10
measure: Analgesic Use Over Time
timeFrame: On days 1-11 and for 10 weeks after therapy
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Loprinzi, M.D.
role: STUDY_CHAIR
References: