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

Primary Purpose

Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

questionnaire administration

Sensory Neuropathy Scale instrument

Quality of Life instrument

MC5-A Scrambler device

About this trial

This is an interventional supportive care trial for Chemotherapeutic Agent Toxicity focused on measuring pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific, peripheral neuropathy

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MC5-A Scramble instrument

Arm Description

Treatment of chronic neuropathic pain with the MC5-A device

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Effect of MC5-A on Pain and Neuropathy

Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.

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

The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention

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

Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.

Full Information

NCT ID

NCT00952848

First Posted

August 4, 2009

Last Updated

February 27, 2017

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00952848

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 12, 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MC5-A Scramble instrument

Arm Type

Experimental

Arm Description

Treatment of chronic neuropathic pain with the MC5-A device

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Pain Rating Score

Intervention Type

Other

Intervention Name(s)

Sensory Neuropathy Scale instrument

Intervention Description

ECOG Common Toxicity Criteria for Sensory Neuropathy scale

Intervention Type

Other

Intervention Name(s)

Quality of Life instrument

Intervention Description

Uniscale 0-100 scale global quality of life

Intervention Type

Device

Intervention Name(s)

MC5-A Scrambler device

Intervention Description

Electrical stimulation for 60 minutes

Primary Outcome Measure Information:

Title

Change in Pain Score

Description

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)

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Effect of MC5-A on Pain and Neuropathy

Description

Time Frame

2 weeks

Title

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

Description

Time Frame

2 weeks

Title

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

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J. Smith, MD

Organizational Affiliation

Massey Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

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

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