Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

NCT ID: NCT01855607

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-11-30

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

Conditions

Breast Cancer; Colon Cancer; Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

topical menthol

Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.

Group Type: EXPERIMENTAL

topical menthol

Intervention Type: DRUG

7.5% Methylsalicylate / 2% Menthol Lotion

placebo lotion

Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.

Group Type: ACTIVE_COMPARATOR

placebo lotion

Intervention Type: DRUG

The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

Interventions

topical menthol

7.5% Methylsalicylate / 2% Menthol Lotion

Intervention Type: DRUG

placebo lotion

The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

Intervention Type: DRUG

Other Intervention Names

RX-116; RX-115

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dawn L. Hershman

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Hershman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAL2664

Identifier Type: -

Identifier Source: org_study_id