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
  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
Neurotoxicity Syndromes
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
Drug: duloxetine hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

Resource links provided by NLM:


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: 242
Study Start Date: April 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: duloxetine hydrochloride
Given orally
Other: placebo
Given orally
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.
Drug: duloxetine hydrochloride
Given orally
Other: placebo
Given orally

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489411

  Show 475 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Ellen L. Smith, PhD, ARNP, AOCN University of Michigan
Principal Investigator: Richard L. Schilsky, MD University of Chicago
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00489411     History of Changes
Other Study ID Numbers: CDR0000553389, CALGB-170601
Study First Received: June 20, 2007
Last Updated: March 4, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Chemically-Induced Disorders
Nervous System Diseases
Neuromuscular Diseases
Poisoning
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014