Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Condition: Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: duloxetine hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific; neurotoxicity; pain; peripheral neuropathy

Summary:

      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.
    

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