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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01196442
First received: September 3, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention
Cancer-related Problem/Condition
Neurotoxicity
Pain
Peripheral Neuropathy
Other: electrical stimulation pain therapy
Other: questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in Pain Score From Day 1 to Day 10 [ Time Frame: From day 1 to day 10 ] [ Designated as safety issue: No ]

    Change in Brief Pain Inventory (Now)Scale

    1 (none) to 5 (complete interference)



Secondary Outcome Measures:
  • Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics [ Time Frame: From day 1 to day 30 ] [ Designated as safety issue: No ]
    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

  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    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.

  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1 [ Time Frame: month 1 ] [ Designated as safety issue: No ]
    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.

  • Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2 [ Time Frame: month 2 ] [ Designated as safety issue: No ]
    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.

  • Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196442

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

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01196442     History of Changes
Other Study ID Numbers: MCC-13098, NCI-2010-01945
Study First Received: September 3, 2010
Results First Received: October 11, 2012
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 15, 2014