A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00815685
First received: December 29, 2008
Last updated: December 13, 2013
Last verified: December 2013
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer Cachexia
Intervention: Drug: Eicosapentaenoic Acid

  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
Eligible participants will include cancer patients with Men and Women >25 years of age (inclusive), with a confirmed diagnosis of cancer, unintentional weight loss of >5% of body weight, using uniform established diagnostic criteria and be admitted to the study within 3 month of diagnosis.

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
Eicosapentaenoic Acid (Lovaza) Participants to receive Lovaza at a dose of 4 g for 6 weeks.

Participant Flow:   Overall Study
    Eicosapentaenoic Acid (Lovaza)  
STARTED     36  
COMPLETED     14 [1]
NOT COMPLETED     22  
[1] Complete pre and post-treatment serum samples were available for 14 participants.



  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.
No text entered.

Reporting Groups
  Description
Eicosapentaenoic Acid (Lovaza) Participants to receive Lovaza at a dose of 4 g for 6 weeks.

Baseline Measures
    Eicosapentaenoic Acid (Lovaza)  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     19  
Gender  
[units: participants]
 
Female     13  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
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1.  Primary:   Change in Serum Albumin   [ Time Frame: 6 weeks per patient ]

2.  Secondary:   Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.   [ Time Frame: 6 weeks per patient ]


  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
This was a Pilot Supportive Care Intervention.


  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: Nagi Kumar, Ph.D., via Moffitt Cancer Center
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6885
e-mail: nagi.kumar@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00815685     History of Changes
Other Study ID Numbers: MCC-15190
Study First Received: December 29, 2008
Results First Received: April 27, 2011
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration