Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
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.
|Neurotoxicity Pain Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific||Drug: ketamine/amitriptyline NP-H cream Other: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Assessment of Topical Treatment Response With Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN)|
- Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo [ Time Frame: 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).
|Study Start Date:||October 2007|
|Study Completion Date:||November 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: ketamine/amitriptyline NP-H cream
Subjects were instructed to apply up to, but not exceeding, 4 g of ketamine/amitriptyline NP-H cream two times per day to each area with pain, numbness, and/or tingling. A measuring device was provided to assist in dispensing the proper amount of the cream.
Other Name: EpiCept NP-1
Placebo Comparator: Placebo Cream
Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471445
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|MBCCOP - University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612-7323|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|St. Louis Park, Minnesota, United States, 55416|
|United States, Nevada|
|CCOP - Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|East Syracuse, New York, United States, 13057|
|CCOP - North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Winston-Salem, North Carolina, United States, 27104-4241|
|United States, Oregon|
|CCOP - Columbia River Oncology Program|
|Portland, Oregon, United States, 97225|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Washington|
|CCOP - Virginia Mason Research Center|
|Seattle, Washington, United States, 98101|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Supriya Mohile, MD||James P. Wilmot Cancer Center|