|Phase III||Supportive care||Closed||25 and over||NCI, Other||CDR0000553389|
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.
Further Study Information
- Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.
- 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.
- 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)
- 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
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group BNational Cancer Institute
|Ellen Lavoie Smith||Study Chair|
|Richard L. Schilsky||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00489411
Information obtained from ClinicalTrials.gov on February 13, 2013
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