Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Conditions
Breast Cancer - Colon Cancer
Conditions: Keywords
chemotherapy induced neuropathy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: topical menthol Type: Other
Name: placebo cream Type: Other
Overall Status
Recruiting
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.
Detailed Description
To assess whether six week treatment with BID topical Menthol application will decrease persistent neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following neoadjuvant/adjuvant chemotherapy with taxanes or oxaliplatin-based regimens among breast and colorectal cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age>21 years

2. History of stage I-III breast or colorectal cancer

3. Patient has to have completed adjuvant or neo-adjuvant Taxane based breast cancer therapy or Oxaliplatin based colon cancer chemotherapy between one and 24 months prior to registration

4. Signed informed consent

5. Concomitant biologic, hormonal or radiation therapy are acceptable.

6. 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.

7. Pain as defined by BPI worst pain greater than or equal to a 5 out of 10.

8. CIPN as defined by experiencing neuropathy (numbness, tingling, thermal hyperalgesia or cold allodynia) in the hands and feet frequently or most of the time in the past seven days.

Exclusion Criteria:

1. Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months

2. Known diabetic neuropathy

3. Severe concomitant illnesses

4. Known allergy or preexisting skin disease which prohibits use of menthol

5. Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
Location
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Katherine Crew - dlh23@columbia.edu
Start Date
August 2013
Completion Date
July 2016
Sponsors
Columbia University
Source
Columbia University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page