Clinical trial NCT01196442: Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Neurotoxicity
Pain
Peripheral Neuropathy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Change in Pain Score From Day 1 to Day 10
timeFrame: From day 1 to day 10
Secondary outcomes:
measure: Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
timeFrame: Day 1
measure: Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
timeFrame: From day 1 to day 30
measure: Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10
timeFrame: Day 10
measure: Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1
timeFrame: month 1
measure: Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2
timeFrame: month 2
measure: Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3
timeFrame: Month 3
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Craig Swainey, MD
role: PRINCIPAL_INVESTIGATOR
References: