Clinical trial NCT00489411 (phase 3, status: completed)
Conditions: neurotoxicity, pain, peripheral neuropathy, unspecified adult solid tumor, protocol specific
ICD codes: G92.00, G92.01, G92.02, G92.03, G92.04, G92.05, N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, G90.09, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: duloxetine hydrochloride
SMILES: CNCC[C@H](OC1=CC=CC2=CC=CC=C12)C1=CC=CS1
Eligibility 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