Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Neurotoxicity Syndromes Pain Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific |
Drug: duloxetine hydrochloride Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy |
- Average pain as measured by the BPI-SF
- Peripheral neuropathy-related functional status
- Quality of life as measured by FACT/COG-NTX and EORTC QLQ-C30 questionnaires in weeks 1, 6, 8, and 13
| Estimated Enrollment: | 242 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: duloxetine hydrochloride
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm II
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
Other: placebo
Given orally
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.
Secondary
- Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.
- Describe the differences in duloxetine hydrochloride efficacy when used to treat pain caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and class.
OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin vs other taxane agents without paclitaxel vs platinum agents [cisplatin] without oxaliplatin) and high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: 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.
- Arm II: 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.
Patients complete pain and quality of life questionnaires, including the BPI-SF once 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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cancer
- CNS malignancy allowed with the exception of leptomeningeal carcinomatosis
Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes)
- CIPN > grade 1 as measured by NCI-CTCAE v 4.0
- Average neuropathic pain score ≥ 4
Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:
- Diabetes mellitus
- Peripheral vascular disease
- HIV infection
- Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy
- No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)
PATIENT CHARACTERISTICS:
- AST ≤ 3 times upper limit of normal
- Total bilirubin ≤ normal
- Creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Able to take oral or enteral medication
- No history of seizure disorder
- No diagnosis of ethanol addiction or dependence within the past 10 years
- No history of narrow-angle glaucoma
None of the following:
- History of suicidal thoughts
- Symptoms of or history of schizophrenia, bipolar disease, or a major depression
- Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely
PRIOR CONCURRENT THERAPY:
- At least 3 months since prior and no concurrent taxane or platinum agent
- At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants
- No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)
- No concurrent anticonvulsants
No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA)
- Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed
- Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E
- No concurrent treatment (pharmacologic) for depression
Contacts and Locations
Show 475 Study Locations| Study Chair: | Ellen L. Smith, PhD, ARNP, AOCN | University of Michigan |
| Principal Investigator: | Richard L. Schilsky, MD | University of Chicago |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00489411 History of Changes |
| Other Study ID Numbers: | CDR0000553389, CALGB-170601 |
| Study First Received: | June 20, 2007 |
| Last Updated: | March 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific neurotoxicity pain peripheral neuropathy |
Additional relevant MeSH terms:
|
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 Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013