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N/A Completed N=39 Supportive Care

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

Cancer-related Problem/Condition · Neurotoxicity · Postoperative Pain · peripheral neuropathy
Source: ClinicalTrials.gov NCT01196442 ↗
Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Feb 2013
Primary outcomePrimary: Change in Pain Score From Day 1 to Day 10 — -3.3 units on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pain Score From Day 1 to Day 10
-3.3
SECONDARY
Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1
20.4129; 15.6268
SECONDARY
Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics
28.9
SECONDARY
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10
17.8305; 14.1815
SECONDARY
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1
16.5207; 13.5443
SECONDARY
Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2
16.4723; 13.3816
SECONDARY
Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3
17.3325; 12.8499

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01196442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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