NCT00489411
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
PHASE3
COMPLETED
NCT00489411
INTERVENTIONAL
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.
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
Neurotoxicity
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
- SUPPORTIVE_CARE
-
- Type: DRUG
- Name: duloxetine hydrochloride
- Description: Given orally
- Arm Group Labels: Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine)
-
- Type: OTHER
- Name: placebo
- Description: Given orally
- Arm Group Labels: Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine)
- Alliance for Clinical Trials in Oncology