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Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01196442
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : February 12, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Neurotoxicity Pain Peripheral Neuropathy Other: electrical stimulation pain therapy Other: questionnaire administration Not Applicable

Detailed Description:

OBJECTIVES:

I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time.

II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate the effect of MC5-A on daily opioid and other pain medication use.

OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days. After completion of study treatment, patients are followed up for 3 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness
Study Start Date : September 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I electric stimulation pain therapy
Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
 Other: electrical stimulation pain therapy
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
Other Names:
  • Calmare
  • analgesia
  • cancer pain management
  • management of cancer pain
  • pain management
  • therapy, pain

Other: questionnaire administration
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain Score From Day 1 to Day 10 [ Time Frame: From day 1 to day 10 ]

    Change in Brief Pain Inventory (Now)Scale

    1 (none) to 5 (complete interference)



Secondary Outcome Measures :
  1. Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 [ Time Frame: Day 1 ]
    Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.

  2. Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics [ Time Frame: From day 1 to day 30 ]
    Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most

  3. Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 [ Time Frame: Day 10 ]
    Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.

  4. Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 [ Time Frame: month 1 ]
    Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.

  5. Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 [ Time Frame: month 2 ]
    Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.

  6. Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 [ Time Frame: Month 3 ]
    Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CIPN neuropathy: received, or currently receiving, 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)
  • Pain or symptoms of peripheral neuropathy of >= 1 months duration attributed to chemotherapy-induced peripheral neuropathy
  • OR pain of the other types including chemotherapy-induced peripheral neuropathy, numbness predominant; post mastectomy pain; post surgical pain; post herpetic neuropathy; post radiation pain; other (vertebral compression, fracture, miscellaneous)
  • The pain must have been stable for at least 2 weeks
  • An average daily pain rating of >= 5 out of 10, using the pain numerical rating scale (NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the patient at least "a little bit" on the CIPN-20
  • Life expectancy >= 3 months
  • ECOG performance status 0, 1, or 2

Exclusion Criteria:

  • Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.)
  • Use of an investigational agent for pain control concurrently or =< 30 days
  • History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation
  • 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)
  • 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
  • Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks
  • Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196442


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Craig Swainey, MD Virginia Commonwealth University
More Information
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Additional Information:

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01196442    
Other Study ID Numbers: MCC-13098
NCI-2010-01945 ( Registry Identifier: CTRP )
First Posted: September 8, 2010    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: August 23, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases