NCT00815685

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cancer Cachexia

Interventions

Type	Name	Description
DRUG	Eicosapentaenoic Acid	Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-03-01
• Completion: 2010-08-01
• First posted: 2008-12-30
• Last updated: 2017-03-23
• Results posted: 2011-09-08

Locations

2 sites across 1 country: United States