- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥21 years
- History of stage I-III breast, gastrointestinal or gynecologic cancer
- Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
- Must exhibit a typical symptom of CIPN that was not present prior to chemotherapy. Symptoms include numbness, tingling, thermal hyperalgesia, cold allodynia in the hands and/or feet, muscle weakness or unsteady gait in at least two of the last seven days prior to registration.
- Signed informed consent
- Concomitant biologic, hormonal, or radiation therapy are acceptable
- Narcotics, antidepressants or other medications for the treatment of CIPN are permitted, if patient on a stable dose for at least one month prior to enrollment
Exclusion Criteria:
- Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months
- Known diabetic neuropathy
- Severe concomitant illnesses
- Known allergy or preexisting skin disease which prohibits use of menthol
- Any topical treatment for neuropathy or other serious skin condition on the hands or feet.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: topical menthol
Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
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7.5% Methylsalicylate / 2% Menthol Lotion
Other Names:
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Active Comparator: placebo lotion
Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
|
The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brief Pain Inventory-Short Form Score
Time Frame: Baseline and 6 weeks
|
The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy.
The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work.
The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in EORTC-CIPN20 Score
Time Frame: Baseline and 6 weeks
|
The European Organization for Research and Treatment of Cancer Chemotherapy-induced peripheral neuropathy (EORTC-CIPN20) is a questionnaire measuring patient reported symptoms of chemotherapy induced neuropathy.
Scores range from 20-80 with a higher score indicating a worse outcome.
|
Baseline and 6 weeks
|
Change in Sensorimotor Function
Time Frame: Baseline 6 weeks
|
Sensorimotor function as measured by a Bio-Thesiometer, which measures changes in vibratory perception.
The Bio-Thesiometer is an electrical tuning fork whose amplitude can be gradually increased.
Vibration threshold will be assessed at the dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux.
Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.)
The vibration perception threshold is the average of three paired measurements.
|
Baseline 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAL2664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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