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| Sponsor: | University of Rochester |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00471445 |
Purpose
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 |
|---|---|---|
|
Neurotoxicity Pain Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ketamine/amitriptyline NP-H cream Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| 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 Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: ketamine/amitriptyline NP-H cream
Applied topically
|
|
Placebo Comparator: Arm II
Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
|
Other: placebo
Applied topically
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Gary R. Morrow, James P. Wilmot Cancer Center at University of Rochester Medical Center |
| ClinicalTrials.gov Identifier: | NCT00471445 History of Changes |
| Other Study ID Numbers: | CDR0000543103, U10CA037420, URCC-0605, URCC-07004 |
| Study First Received: | May 8, 2007 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific pain neurotoxicity peripheral neuropathy |
|
Peripheral Nervous System Diseases Neurotoxicity Syndromes Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neuromuscular Diseases Nervous System Diseases Poisoning Substance-Related Disorders Signs and Symptoms Amitriptyline Ketamine Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |