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Trial record 1 of 2 for:    S1202
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S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

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ClinicalTrials.gov Identifier: NCT01598298
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Results First Posted : February 28, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Breast Cancer
Musculoskeletal Complications
Pain
Interventions: Drug: duloxetine hydrochloride
Other: placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Arm I: Duloxetine

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Arm II: Placebo

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO


Participant Flow:   Overall Study
    Arm I: Duloxetine   Arm II: Placebo
STARTED   150   149 
Patients Evaluable for Primary Endpoint [1]   127   128 
Patients Evaluable for Adverse Events   138   141 
COMPLETED   110   108 
NOT COMPLETED   40   41 
Not eligible                5                5 
Adverse Event                21                19 
Progression/relapse                0                2 
Withdrawal by Subject                10                15 
Other reason (not protocol specified)                4                0 
[1] Patient has an in-window BPI assessment at week 2, 6, or 12.



  Baseline Characteristics

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.
Eligible patients

Reporting Groups
  Description
Arm I: Duloxetine

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Arm II: Placebo

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO

Total Total of all reporting groups

Baseline Measures
   Arm I: Duloxetine   Arm II: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   144   289 
Age 
[Units: Years]
Median (Full Range)
 60 
 (40 to 83) 
 60 
 (27 to 82) 
 60 
 (27 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      145 100.0%      144 100.0%      289 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   3.4%      6   4.2%      11   3.8% 
Not Hispanic or Latino      140  96.6%      137  95.1%      277  95.8% 
Unknown or Not Reported      0   0.0%      1   0.7%      1   0.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      2   1.4%      2   0.7% 
Asian      6   4.1%      3   2.1%      9   3.1% 
Native Hawaiian or Other Pacific Islander      1   0.7%      0   0.0%      1   0.3% 
Black or African American      10   6.9%      17  11.8%      27   9.3% 
White      128  88.3%      120  83.3%      248  85.8% 
More than one race      0   0.0%      1   0.7%      1   0.3% 
Unknown or Not Reported      0   0.0%      1   0.7%      1   0.3% 
Baseline pain score [1] 
[Units: Participants]
Count of Participants
     
4-6      110  75.9%      110  76.4%      220  76.1% 
7-10      35  24.1%      34  23.6%      69  23.9% 
[1] Baseline pain score is the patient's self-reported average pain at baseline as measured by the BPI-SF question, "Please rate your joint pain by selecting the one number that best describes your joint pain on the AVERAGE". This score ranges from 0 to 10, with higher scores indicating more pain.
Prior taxane use 
[Units: Participants]
Count of Participants
     
No      68  46.9%      65  45.1%      133  46.0% 
Yes      77  53.1%      79  54.9%      156  54.0% 


  Outcome Measures

1.  Primary:   Average Joint Pain According to BPI-SF   [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]

2.  Secondary:   Worst Joint Pain According to the BPI-SF   [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]

3.  Secondary:   Pain Interference According to the BPI-SF   [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Leukemia Committee Statistician
Organization: SWOG Statistics and Data Management Center
phone: 2066674623
e-mail: amoseley@fredhutch.org



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01598298     History of Changes
Other Study ID Numbers: S1202
S1202 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2012-01960 ( Other Identifier: NCI )
First Submitted: May 11, 2012
First Posted: May 15, 2012
Results First Submitted: January 31, 2018
Results First Posted: February 28, 2018
Last Update Posted: April 2, 2018