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Trial record 1 of 1 for:    S0927
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S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01385137
First received: June 28, 2011
Last updated: February 23, 2017
Last verified: February 2017
Results First Received: November 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Supportive Care
Conditions: Arthralgia
Breast Cancer
Pain
Interventions: Dietary Supplement: omega-3 fatty acid
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
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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 (Omega-3-fatty Acid) Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
Arm II (Placebo) Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity

Participant Flow for 2 periods

Period 1:   Evaluable at Baseline
    Arm I (Omega-3-fatty Acid)   Arm II (Placebo)
STARTED [1]   131   131 
COMPLETED   122   127 
NOT COMPLETED   9   4 
[1] 9 patients on arm 1 and 4 patients on arm 2 found ineligible after registration

Period 2:   Evaluable for Primary Endpoint
    Arm I (Omega-3-fatty Acid)   Arm II (Placebo)
STARTED   131   131 
COMPLETED   102   107 
NOT COMPLETED   29   24 



  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.
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Reporting Groups
  Description
Arm I (Omega-3-fatty Acid) Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
Arm II (Placebo) Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Total Total of all reporting groups

Baseline Measures
   Arm I (Omega-3-fatty Acid)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   127   249 
Age 
[Units: Years]
Median (Full Range)
 59.5 
 (40 to 84) 
 59.1 
 (43 to 83) 
 59.2 
 (40 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      122 100.0%      127 100.0%      249 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      7   5.7%      9   7.1%      16   6.4% 
Not Hispanic or Latino      112  91.8%      113  89.0%      225  90.4% 
Unknown or Not Reported      3   2.5%      5   3.9%      8   3.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   113   104   217 
Black   5   15   20 
Asian   1   3   4 
Native American   0   1   1 
Multiracial   1   1   2 
Unknown   2   3   5 
Osteoarthritis 
[Units: Participants]
Count of Participants
     
Yes   28   29   57 
No   94   98   192 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score   [ Time Frame: 12 weeks post-registration ]

2.  Secondary:   Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug   [ Time Frame: Up to 25 weeks ]

3.  Secondary:   Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score   [ Time Frame: 12 weeks post-registration ]

4.  Secondary:   Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score   [ Time Frame: 12 weeks post-registration ]

5.  Secondary:   Week 12 Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES) Score   [ Time Frame: 12 weeks post-registration ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01385137     History of Changes
Other Study ID Numbers: S0927
S0927 ( Other Identifier: SWOG )
U10CA037429 ( US NIH Grant/Contract Award Number )
Study First Received: June 28, 2011
Results First Received: November 15, 2016
Last Updated: February 23, 2017