NCT01855607

Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy

Conditions

• Breast Cancer
• Colon Cancer
• Neuropathy

Interventions

Type	Name	Description
DRUG	topical menthol	7.5% Methylsalicylate / 2% Menthol Lotion
DRUG	placebo lotion	The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-05-16
• Last updated: 2024-07-11
• Results posted: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study