Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
Condition: Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): ketamine/amitriptyline NP-H cream; placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; Applied topically
Other intervention name(s): EpiCept NP-1
Intervention MeSH terms: Ketamine; Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: unspecified adult solid tumor, protocol specific; pain; neurotoxicity; peripheral neuropathy