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

Pain Clinical Trial

Official title:

Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290224
• Other study ID #: MC10C8
• Secondary ID: NCI-2011-0010910
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2011
• Last updated: January 16, 2014
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• scrambler therapy
Undergo MC5-A therapy

Procedure:
• sham intervention
Undergo sham procedure

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question	The 12 CIPN symptoms individual question 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 (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.	On days 1 and 2	No
Secondary	Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire	The 12 CIPN symptoms individual question 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 (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).	Day 1 and Day 10	No
Secondary	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	The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.	Week 1 and Week 10	No
Secondary	Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions	The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.	Day 1 and Week 10	No
Secondary	Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0	CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.	Day 1 to Day 10	Yes
Secondary	Analgesic Use Over Time		On days 1-11 and for 10 weeks after therapy	No