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Sponsors and Collaborators: |
University of Rochester National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00471445 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Pain Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ketamine/amitriptyline NP-H cream Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Assessment of Topical Treatment Response With Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN) |
Estimated Enrollment: | 400 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
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Drug: ketamine/amitriptyline NP-H cream
Applied topically
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Arm II: Placebo Comparator
Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
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Other: placebo
Applied topically
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OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pain, numbness, or tingling in the hands or feet beginning in association with a cancer chemotherapy agent (taxane or other chemotherapeutic agent) and persisting for at least 28 days following the conclusion of chemotherapy
Patients with stable systemic metastases and/or bone involvement AND has not received chemotherapy within 3 months of screening assessment are eligible
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent monoamine oxidase inhibitors, barbiturates, anticholinergic agents, or sympathomimetic drugs, including epinephrine combined with local anesthetics
Concurrent opioid analgesics, tricyclic or dual reuptake inhibitor antidepressants, or gabapentin or pregabalin for CPN, or benzodiazepines for sleep allowed, provided dose has been stable for ≥ 2 weeks and the following are true:
United States, New York | |
University of Rochester Cancer Center CCOP Research Base | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Gary R. Morrow, PhD, MS 585-275-5513 |
Study Chair: | Supriya Mohile, MD | James P. Wilmot Cancer Center |
Responsible Party: | James P. Wilmot Cancer Center at University of Rochester Medical Center ( Gary R. Morrow ) |
Study ID Numbers: | CDR0000543103, URCC-0605, URCC-07004 |
Study First Received: | May 8, 2007 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00471445 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific pain neurotoxicity |
Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Neurotoxicity Syndromes Adrenergic Agents Psychotropic Drugs Central Nervous System Depressants Anesthetics Pain Anesthetics, Dissociative |
Antidepressive Agents, Tricyclic Neuromuscular Diseases Anesthetics, General Analgesics, Non-Narcotic Peripheral Nervous System Diseases Ketamine Amitriptyline Analgesics Peripheral Nervous System Agents Antidepressive Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Anesthetics Excitatory Amino Acid Agents Neuromuscular Diseases Sensory System Agents Therapeutic Uses Ketamine Analgesics |
Antidepressive Agents Excitatory Amino Acid Antagonists Anesthetics, Intravenous Nervous System Diseases Central Nervous System Depressants Pharmacologic Actions Anesthetics, Dissociative Antidepressive Agents, Tricyclic Analgesics, Non-Narcotic Anesthetics, General Peripheral Nervous System Diseases Amitriptyline Peripheral Nervous System Agents Central Nervous System Agents |