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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.

Detailed Summary:

People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.

Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.


Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Change in Serum Albumin [ Time Frame: 6 weeks per patient ]

Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.


Original Primary Outcome: Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers. Treatment Toxicity associated with this regimen. [ Time Frame: 6 weeks per patient ]

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

There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.


Original Secondary Outcome: To explore the fundamental molecular pathways of Lovaza as indicated by observing changes in levels of proteasome activity (IkB-α protein expression, and NFkB DNA-binding activity) in serum. [ Time Frame: 6 weeks per patient ]

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: December 29, 2008
Date Started: July 2007
Date Completion:
Last Updated: February 20, 2017
Last Verified: December 2013