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Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00489411
  Purpose

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.


Condition Intervention Phase
Cancer-Related Problem/Condition
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: duloxetine hydrochloride
Drug: placebo
Phase III

MedlinePlus related topics: Cancer Peripheral Nerve Disorders
Drug Information available for: Duloxetine Duloxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Trial of Oral Duloxetine for Treatment of Painful Chemotherapy-Induced Peripheral Neuropathy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Average pain as measured by the BPI-SF

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 206
Study Start Date: April 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
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.
Drug: duloxetine hydrochloride
Given orally
Drug: placebo
Given orally
Arm II: Experimental
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.
Drug: duloxetine hydrochloride
Given orally
Drug: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to prior neurotoxic agent (paclitaxel vs 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-SFonce 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer

    • CNS malignancy allowed with the exception of leptomeningeal carcinomatosis
  • Must have sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior paclitaxel OR oxaliplatin administration (may not have received both agents)

    • CIPN ≥ grade 2 as measured by NCI-CTCAE v 3.0
    • 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
  • Bilirubin normal
  • Creatinine clearance > 30 mL/min
  • 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
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • At least 3 months since prior and no concurrent paclitaxel or oxaliplatin
  • At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants
  • No other prior or concurrent neurotoxic drugs (e.g., docetaxel, cisplatin, vincristine, vinblastine, cytarabine, thalidomide, bortezomib, or procarbazine)
  • No concurrent anticonvulsants
  • No concurrent warfarin or heparin
  • No concurrent 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 B_6, E, and B_12 allowed
  • No concurrent treatment (pharmacologic or psychotherapy) for depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489411

  Show 59 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Ellen L. Smith, PhD, ARNP, AOCN Norris Cotton Cancer Center
Principal Investigator: Richard L. Schilsky, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000553389, CALGB-170601
Study First Received: June 20, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00489411  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
neurotoxicity
pain

Study placed in the following topic categories:
Dopamine
Neuromuscular Diseases
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neurotoxicity syndromes
Pain
Serotonin
Duloxetine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009