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NCT01855607 · ClinicalTrials.gov registry record · Phase 2
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01855607 is a Phase 2 study that was terminated before completion, run by Columbia University. The registered enrollment target is 12 participants.
The verdict
NCT01855607, a Phase 2 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG topical menthol
- DRUG placebo lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01855607
The ClinicalTrials.gov registry entry for NCT01855607 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which topical menthol is the first listed.
NCT01855607 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01855607 about?
NCT01855607 is a clinical study titled "Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy". 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-ba...
What is the current status of trial NCT01855607?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-08. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01855607?
The interventions under investigation include: topical menthol (DRUG), placebo lotion (DRUG).
Who is sponsoring clinical trial NCT01855607?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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