Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Sponsor

Columbia University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01855607

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Prevalence of decrease in neuropathic pain [6 weeks]
measured by BPI-SF scale

Secondary Outcome Measures

Change in sensory and motor function [6 weeks]
grooved pegboard and vibrometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age>21 years
History of stage I-III breast or colorectal cancer
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
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.
Pain as defined by BPI worst pain greater than or equal to a 5 out of 10.
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
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator: Dawn Hershman, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Columbia University

ClinicalTrials.gov Identifier:

NCT01855607

Other Study ID Numbers:

AAAL2664

First Posted:

May 16, 2013

Last Update Posted:

Jul 2, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Columbia University

chemotherapy induced neuropathy

Additional relevant MeSH terms:

Colonic Neoplasms

Menthol

Study Results

No Results Posted as of Jul 2, 2015