Breast Cancer Clinical Trial
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Summary
To assess whether six week treatment with twice a day topical Menthol application will decrease persistent neuropathic pain from chemotherapy among breast and colorectal cancer patients.
Full Description
Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy
Eligibility Criteria
Inclusion Criteria:
Age≥21 years
History of stage I-III breast, gastrointestinal or gynecologic cancer
Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
Must exhibit a typical symptom of CIPN that was not present prior to chemotherapy. Symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration.
Signed informed consent
Concomitant biologic, hormonal, or radiation therapy are acceptable
Narcotics, antidepressants or other medications for the treatment of CIPN are permitted, if patient on a stable dose for at least one month prior to enrollment
Exclusion Criteria:
Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months
Known diabetic neuropathy
Severe concomitant illnesses
Known allergy or preexisting skin disease which prohibits use of menthol
Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
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There is 1 Location for this study
New York New York, 10032, United States
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