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

NCT01196442 | Completed Results DMC

• 2 other identifiers: MCC-13098NCI-2010-01945
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Problem/Condition; Neurotoxicity; Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score From Day 1 to Day 10

  Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)

  From day 1 to day 10

Secondary Outcomes (6)

• Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1

  Day 1

• Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics

  From day 1 to day 30

• Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10

  Day 10

• Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1

  month 1

• Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2

  month 2

Study Arms (1)

Arm I electric stimulation pain therapy

EXPERIMENTAL

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

Other: electrical stimulation pain therapy; Other: questionnaire administration

Interventions

electrical stimulation pain therapy OTHER

Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10

Also known as: Calmare, analgesia, cancer pain management, management of cancer pain, pain management, therapy, pain

Arm I electric stimulation pain therapy

questionnaire administration OTHER

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

Arm I electric stimulation pain therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Links

• VCU Massey Cancer Center

MeSH Terms

Conditions

Neurotoxicity Syndromes; Pain; Peripheral Nervous System Diseases

Interventions

Analgesia; Pain Management

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Craig W. Swainey
• Organization: Virginia Commonwealth University

cswainey@mcvh-vcu.edu

804-828-9723

Study Officials

• Craig Swainey, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 23, 2013
• Results First Posted: February 12, 2013

Record last verified: 2013-08

Locations

US (1)