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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
Results First Received: December 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Investigator;   Primary Purpose: Supportive Care
Conditions: Neurotoxicity
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: duloxetine hydrochloride
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of screened and the number offered participation but declined was not captured.

Reporting Groups
  Description
Arm I/Group A (Duloxetine Then Placebo) Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Arm II/Group B (Placebo Then Duloxetine) Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).

Participant Flow for 3 periods

Period 1:   Initial Treatment Period (Weeks 1-5)
    Arm I/Group A (Duloxetine Then Placebo)   Arm II/Group B (Placebo Then Duloxetine)
STARTED   115   116 
COMPLETED   87   94 
NOT COMPLETED   28   22 
Withdrew consent prior to intervention                6                5 
Discontinued study drug early                21                12 
Incomplete data                1                5 

Period 2:   Washout Period (Weeks 6-7)
    Arm I/Group A (Duloxetine Then Placebo)   Arm II/Group B (Placebo Then Duloxetine)
STARTED   87   94 
COMPLETED [1]   85   93 
NOT COMPLETED   2   1 
[1] Reasons for why patients did not participate in the crossover treatment period were not captured.

Period 3:   Crossover Treatment Period (Weeks 8-12)
    Arm I/Group A (Duloxetine Then Placebo)   Arm II/Group B (Placebo Then Duloxetine)
STARTED   85   93 
COMPLETED   67   74 
NOT COMPLETED   18   19 
Discontinued intervention early                11                12 
Incomplete data                7                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received duloxetine/placebo as randomized were included in the analysis population.

Reporting Groups
  Description
Arm I/Group A (Duloxetine Then Placebo) Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Arm II/Group B (Placebo Then Duloxetine) Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Total Total of all reporting groups

Baseline Measures
   Arm I/Group A (Duloxetine Then Placebo)   Arm II/Group B (Placebo Then Duloxetine)   Total 
Overall Participants Analyzed 
[Units: Participants]
 109   111   220 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (10.4)   59.0  (10.6)   59.0  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      71  65.1%      67  60.4%      138  62.7% 
Male      38  34.9%      44  39.6%      82  37.3% 
Region of Enrollment 
[Units: Participants]
     
United States   109   111   220 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ellen Lavoie Smith, PhD, APRN, AOCN, FAAN
Organization: University of Michigan School of Nursing
phone: 734-936-1267
e-mail: Ellenls@med.umich.edu


Publications of Results:
Lavoie Smith EM, Pang H, Cirrincione C, et al.: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). [Abstract] J Clin Oncol 30 (Suppl 15): A-CRA9013, 2012.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00489411     History of Changes
Other Study ID Numbers: CALGB-170601
CDR0000553389 ( Registry Identifier: NCI Physician Data Query )
Study First Received: June 20, 2007
Results First Received: December 2, 2016
Last Updated: March 16, 2017