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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00489411
First received: June 20, 2007
Last updated: March 16, 2017
Last verified: March 2017
June 20, 2007
March 16, 2017
April 2008
January 2012   (Final data collection date for primary outcome measure)
Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item [ Time Frame: Day 1 of Week 1 to Day 1 of Week 6 ]
Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.
Average pain as measured by the BPI-SF
Complete list of historical versions of study NCT00489411 on ClinicalTrials.gov Archive Site
  • Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score [ Time Frame: Day 1 of Week 1 to Day 1 to Week 6 ]
    Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.
  • Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5 [ Time Frame: Day 1 of Week 1 to Day 1 of Week 6 ]
    Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.
  • Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item [ Time Frame: Day 1 of Week 8 to Day 1 of Week 13 ]
    Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.
  • 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
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
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Supportive Care
  • Neurotoxicity
  • Pain
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: duloxetine hydrochloride
    Given orally
  • Other: placebo
    Given orally
  • Experimental: Arm I/Group A (Duloxetine then Placebo)
    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/Group B (Placebo then Duloxetine)
    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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
March 2013
January 2012   (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
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00489411
CALGB-170601
CALGB-170601
CDR0000553389 ( Registry Identifier: NCI Physician Data Query )
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Ellen L. Smith, PhD, ARNP, AOCN University of Michigan
Alliance for Clinical Trials in Oncology
March 2017

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