Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer, Colon Cancer, Neuropathy

In brief

Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients. Secondary objectives: * To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups. * To compare changes in dose delivery and early treatment discontinuation rates between study groups. * To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing. * To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.

Key facts

Study ID

NCT01855607

Run by

Columbia University

People needed

12

Starts

2013-08-01

Expected to finish

2016-11-01

Last updated by the study team

2024-07-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age≥21 years
• History of stage I-III breast, gastrointestinal or gynecologic cancer
• Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
• Must exhibit a typical symptom of CIPN that was not present prior to chemotherapy. Symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days 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

You may not qualify if…

• 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.

Where it is running

• Herbert Irving Comprehensive Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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