Status:
TERMINATED
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Lead Sponsor:
Columbia University
Conditions:
Breast Cancer
Colon Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01855607
Start Date
August 1 2013
End Date
November 1 2016
Last Update
July 11 2024
Active Locations (1)
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1
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032