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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00489411
First received: June 20, 2007
Last updated: March 4, 2011
Last verified: March 2011

June 20, 2007
March 4, 2011
April 2008
January 2010   (final data collection date for primary outcome measure)
Average pain as measured by the BPI-SF
Same as current
Complete list of historical versions of study NCT00489411 on ClinicalTrials.gov Archive Site
  • Peripheral neuropathy-related functional status
  • Quality of life as measured by FACT/COG-NTX and EORTC QLQ-C30 questionnaires in weeks 1, 6, 8, and 13
Same as current
Not Provided
Not Provided
 
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
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

  • Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.

Secondary

  • Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.
  • Describe the differences in duloxetine hydrochloride efficacy when used to treat pain caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and class.

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.

  • Arm I: Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
  • Arm II: Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
  • Neurotoxicity Syndromes
  • Pain
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: duloxetine hydrochloride
    Given orally
  • Other: placebo
    Given orally
  • Experimental: Arm I
    Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
    Interventions:
    • Drug: duloxetine hydrochloride
    • Other: placebo
  • Experimental: Arm II
    Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.
    Interventions:
    • Drug: duloxetine hydrochloride
    • Other: placebo
Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
242
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489411
CDR0000553389, CALGB-170601
Not Provided
Not Provided
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Ellen L. Smith, PhD, ARNP, AOCN University of Michigan
Principal Investigator: Richard L. Schilsky, MD University of Chicago
National Cancer Institute (NCI)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP