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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00489411 |
RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Pain Unspecified Adult Solid Tumor, Protocol Specific |
Drug: duloxetine hydrochloride Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Trial of Oral Duloxetine for Treatment of Painful Chemotherapy-Induced Peripheral Neuropathy |
Estimated Enrollment: | 206 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
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Drug: duloxetine hydrochloride
Given orally
Drug: placebo
Given orally
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Arm II: Experimental
Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.
|
Drug: duloxetine hydrochloride
Given orally
Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin) and high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
Patients complete pain and quality of life questionnaires, including the BPI-SFonce weekly and FACT/GOG-NTX and EORTC QLQ-C30 questionnaires, in weeks 1, 6, 8, and 13.
After completion of study treatment, patients are followed for 2 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cancer
Must have sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior paclitaxel OR oxaliplatin administration (may not have received both agents)
Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent vitamin supplementation in doses greater than the recommended daily allowance (RDA)
Study Chair: | Ellen L. Smith, PhD, ARNP, AOCN | Norris Cotton Cancer Center |
Principal Investigator: | Richard L. Schilsky, MD | University of Chicago |
Study ID Numbers: | CDR0000553389, CALGB-170601 |
Study First Received: | June 20, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00489411 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific neurotoxicity pain |
Dopamine Neuromuscular Diseases Neurotoxicity Syndromes Peripheral Nervous System Diseases |
Neurotoxicity syndromes Pain Serotonin Duloxetine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |