Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Inclusion Criteria

• •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