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Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

NCT01855607 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-11

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Dawn Hershman, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855607 on ClinicalTrials.gov