Topical Menthol for the Treatment of Chemotherapy Induced Peripheral

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Breast Cancer
Colon Cancer
Neuropathy
Peripheral Nervous System Diseases

Clinical Trial Details

NCT number	NCT01855607
Study type	Interventional
Source	Columbia University
Contact
Status	Terminated
Phase	Phase 2
Start date	August 2013
Completion date	November 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms