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Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01855607
Recruitment Status : Unknown
Verified June 2015 by Columbia University.
Recruitment status was:  Recruiting
First Posted : May 16, 2013
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colon Cancer Other: topical menthol Other: placebo cream Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Topical Menthol for CIPN: a Randomized, Placebo Controlled Phase II Trial
Study Start Date : August 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: topical menthol
topical menthol cream to hands and feet
Other: topical menthol
7.5% Methylsalicylate / 2% Menthol Lotion

Placebo Comparator: placebo cream
topical cream without menthol
Other: placebo cream
The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

Primary Outcome Measures :
  1. Prevalence of decrease in neuropathic pain [ Time Frame: 6 weeks ]
    measured by BPI-SF scale

Secondary Outcome Measures :
  1. Change in sensory and motor function [ Time Frame: 6 weeks ]
    grooved pegboard and vibrometer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01855607

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Contact: Dawn L Hershman, MD 212 305-1945
Contact: Dan Otap

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United States, New York
Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Katherine Crew   
Sub-Investigator: Katherine Crew, MD         
Principal Investigator: Dawn Hershman, MD         
Sponsors and Collaborators
Columbia University
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Principal Investigator: Dawn Hershman, MD Columbia University

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Responsible Party: Columbia University Identifier: NCT01855607     History of Changes
Other Study ID Numbers: AAAL2664
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015

Keywords provided by Columbia University:
chemotherapy induced neuropathy

Additional relevant MeSH terms:
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Methyl salicylate
Dermatologic Agents
Antirheumatic Agents