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

Phase 2
18 Years
Not Enrolling
Breast Cancer, Colon Cancer

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Trial Information

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

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:

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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

neuropathic pain

Outcome Description:

measured by BPI

Outcome Time Frame:

6 weeks

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • chemotherapy induced neuropathy
  • Breast Neoplasms
  • Colonic Neoplasms
  • Peripheral Nervous System Diseases