Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Summary

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.

Timeline

Start

2013-08

Primary completion

2016-11

Completion

2016-11

Drugs

Indications