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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196442
• Other study ID #: MCC-13098
• Secondary ID: NCI-2010-01945
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: August 21, 2013
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer-related Problem/Condition
• Neurotoxicity
• Neurotoxicity Syndromes
• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• electrical stimulation pain therapy
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
• questionnaire administration
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at 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.	Day 1	No
Secondary	Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics	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	From day 1 to day 30	No
Secondary	Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.	Day 10	No
Secondary	Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.	month 1	No
Secondary	Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at 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.	month 2	No
Secondary	Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at 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.	Month 3	No

External Links

•   VCU Massey Cancer Center