Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients

Phase 3

Completed

• Conditions: Neurotoxicity; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific; Pain
• Interventions: Drug: ketamine/amitriptyline NP-H cream; Other: placebo

• Registration Number: NCT00471445
• Lead Sponsor: Gary Morrow

Brief Summary

RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Detailed Description

OBJECTIVES:

* Compare the analgesic properties and safety of topical amitriptyline and ketamine hydrochloride cream vs placebo in cancer patients with chemotherapy peripheral neuropathy (CPN) who have received taxanes or other cancer chemotherapy agents.

OUTLINE: This is a multicenter, double-blind, randomized, placebo-controlled study. Patients are stratified according to Community Clinical Oncology Program (CCOP) site. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

* Arm II: Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to a total of 12 weeks.

Patients complete a peripheral neuropathy intensity and quality of sleep diary daily. Patients also complete the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN20) to assess change in sensory score and the Brief Pain Inventory and Hospital Anxiety and Depression Scale to assess health-related quality of life in week 3 and 6. The Vulnerable Elders Survey (VES-13) is administered at baseline to assess level of physical activity and the University of Rochester Cancer Center (URCC) symptom inventory is administered to track other potentially important symptoms. The Patient Global Impression of Change Questionnaire is administered in week 6 to assess the patient's overall assessment of change since beginning treatment, including changes in pain, side effects, functional status, and overall satisfaction with treatment.

PROJECTED ACCRUAL: A total of 462 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-10
• Study Start: 2007-10
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Results First Submitted: 2014-08-20
• Results First Submitted QC: 2015-06-08
• Results First Posted: 2015-06-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine/amitriptyline NP-H cream	ketamine/amitriptyline NP-H cream	Patients apply 4 grams amitriptyline (4%) and ketamine (2%) hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
Placebo Cream	placebo	Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.

Primary Outcome Measures

Name	Time	Method
Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo	Week 6 - Baseline	Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in their hands and feet over the past 24 hours" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain).

Trial Locations

Locations (17)

CCOP - North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

CCOP - Nevada Cancer Research Foundation; 🇺🇸 Las Vegas, Nevada, United States

CCOP - Hematology-Oncology Associates of Central New York; 🇺🇸 East Syracuse, New York, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

CCOP - Virginia Mason Research Center; 🇺🇸 Seattle, Washington, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

MBCCOP - Hawaii; 🇺🇸 Honolulu, Hawaii, United States

CCOP - Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

CCOP - Metro-Minnesota; 🇺🇸 St. Louis Park, Minnesota, United States

MBCCOP - University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Northwest; 🇺🇸 Tacoma, Washington, United States

CCOP - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

CCOP - Greenville; 🇺🇸 Greenville, South Carolina, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Winston-Salem, North Carolina, United States

CCOP - Columbia River Oncology Program; 🇺🇸 Portland, Oregon, United States