A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
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.
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 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.
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.
DISEASE CHARACTERISTICS:
Diagnosis of cancer
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)
Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:
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:
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)
No concurrent treatment (pharmacologic) for depression
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