Pain Clinical Trial
Official title:
Assessment of Topical Treatment Response With Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN)
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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