Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy



Status:Recruiting
Conditions:Breast Cancer, Colorectal Cancer, Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:August 2013
End Date:July 2016
Contact:Dawn L Hershman, MD
Email:dlh23@columbia.edu
Phone:212 305-1945

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Topical Menthol for CIPN: a Randomized, Placebo Controlled Phase II Trial

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.

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.

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.
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