Back to resultsTopical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Primary Purpose
Breast Cancer, Colon Cancer, Neuropathy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
topical menthol
placebo lotion
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring chemotherapy induced neuropathy
Eligibility Criteria
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.
Sites / Locations
- Herbert Irving Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
topical menthol
placebo lotion
Arm Description
Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Outcomes
Primary Outcome Measures
Change in Brief Pain Inventory-Short Form Score
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.
Secondary Outcome Measures
Change in EORTC-CIPN20 Score
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.
Change in Sensorimotor Function
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01855607
Brief Title
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Official Title
Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of feasibility
Study Start Date
August 2013 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer, Neuropathy
Keywords
chemotherapy induced neuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
topical menthol
Arm Type
Experimental
Arm Description
Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Arm Title
placebo lotion
Arm Type
Active Comparator
Arm Description
Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Intervention Type
Drug
Intervention Name(s)
topical menthol
Other Intervention Name(s)
RX-116
Intervention Description
7.5% Methylsalicylate / 2% Menthol Lotion
Intervention Type
Drug
Intervention Name(s)
placebo lotion
Other Intervention Name(s)
RX-115
Intervention Description
The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory-Short Form Score
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in EORTC-CIPN20 Score
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in Sensorimotor Function
Description
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.
Time Frame
Baseline 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Hershman, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
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