Clinical trial NCT01855607: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Colon Cancer
Neuropathy
Keywords: chemotherapy induced neuropathy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

1. Age≥21 years
2. History of stage I-III breast, gastrointestinal or gynecologic cancer
3. Must have received at least one taxane or platinum based chemotherapy drug within two years prior to enrollment.
4. 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.
5. Signed informed consent
6. Concomitant biologic, hormonal, or radiation therapy are acceptable
7. 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:

1. Previous treatment with topical menthol (menthol/methylsalicylate products like BenGay, Aspercreme, or Icy Hot) of any concentration within the previous 3 months
2. Known diabetic neuropathy
3. Severe concomitant illnesses
4. Known allergy or preexisting skin disease which prohibits use of menthol
5. Any topical treatment for neuropathy or other serious skin condition on the hands or feet.

Primary outcomes:
measure: Change in Brief Pain Inventory-Short Form Score
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in EORTC-CIPN20 Score
timeFrame: Baseline and 6 weeks
measure: Change in Sensorimotor Function
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References: