Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

NCT01855607 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AAAL2664
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colon Cancer; Neuropathy

Keywords

chemotherapy induced neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Change in EORTC-CIPN20 Score

  Baseline and 6 weeks

• Change in Sensorimotor Function

  Baseline and 6 weeks

Study Arms (2)

topical menthol

EXPERIMENTAL

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

Drug: topical menthol

placebo lotion

ACTIVE COMPARATOR

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

Drug: placebo lotion

Interventions

topical menthol DRUG

7.5% Methylsalicylate / 2% Menthol Lotion

Also known as: RX-116

topical menthol

placebo lotion DRUG

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

Also known as: RX-115

placebo lotion

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Interventions

Menthol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Results Point of Contact

• Title: Dawn L. Hershman, MD, MS, FASCO
• Organization: Columbia University Irving Medical Center

dlh23@columbia.edu

212 305-1945

Study Officials

• Dawn Hershman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2022-10

Locations

US (1)