Assessment of Topical Treatment Response With Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN)
- 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 QLQ-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 VES-13 is administered
at baseline to assess level of physical activity and the 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 400 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Change in average daily peripheral neuropathy intensity score from baseline to week 6 in patients treated with amitriptyline and ketamine hydrochloride vs placebo
Supriya Mohile, MD
James P. Wilmot Cancer Center
United States: Food and Drug Administration
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Greenville||Greenville, South Carolina 29615|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|CCOP - Evanston||Evanston, Illinois 60201|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|CCOP - Virginia Mason Research Center||Seattle, Washington 98101|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|