Cancer Clinical Trial
Official title:
AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss
The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements in maintaining weight in people with disease-related weight loss and/or cachexia.
The overall goal of this project is to evaluate the safety and efficacy of nutritional
supplementation with fish oils to maintain weight in patients with disease-related weight
loss (cachexia). Weight loss commonly results in a poorer prognosis, functional status, and
quality of life. Despite the high morbidity and mortality associated with cachexia,
mainstream treatment does not sustain weight and although nutritional supplements are
commonly used, many of these have not been tested in clinical trials. Recent work in cachexia
has revealed that this is mediated by pro-inflammatory cytokines. There are data that
suggests that fish oils can affect the underlying pathogenic inflammatory response and have
an affect on weight maintenance and nutritional balance
Diseases in which cachexia is most common:
- Cancer
- Chronic Heart Failure (CHF)
- Chronic Obstructive Pulmonary Disease (COPD)
- Rheumatoid Arthritis (RA)
Goals of the Study:
- To evaluate the safety and efficacy of fish oils vs. corn oil in the maintenance of
weight and lean body mass in patients with disease-related weight loss.
- To understand the mechanism of fish oil effect on health maintenance by evaluating the
anti-inflammatory, anti-catabolic, anti-oxidant and anabolic actions of these compounds
- To document the effect of our interventions on quality of life and functional status.
Study Outline:
Participants will be randomly assigned to receive either fish oil supplements or corn oil for
the duration of this 3-month study. Participants will have five study visits and two
telephone interviews. During each study visit, participants will undergo laboratory tests, a
physical exam, and a dual energy X-ray absorptiometry (DEXA) bone scan. Participants will be
asked to keep a food diary during the study. During the telephone interviews, participants
will be asked health-related questions and discuss their current functional status.
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