A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00094562

Purpose

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.

Condition	Intervention	Phase
Cancer Cancer Cachexia Chronic Obstructive Pulmonary Disease Chronic Heart Failure Rheumatoid Arthritis	Drug: Fish oil supplement	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Cancer Dietary Supplements Heart Failure Rheumatoid Arthritis Weight Control

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Body weight
lean body mass

Estimated Enrollment:	60
Study Start Date:	June 2004
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and Women with disease-related weight loss e.g. cardiac cachexia, COPD, CHF, RA.
All stages of Pancreatic cancer patients (No weight loss requirements)
All stages of cancer with 5% weight loss
At least 6 weeks post-surgery
On a stable dose of medications for at least 6 weeks prior to study entry
Most recent ECOG Performance status score of 0,1,2,or 3 if applicable
Agree to use acceptable methods of contraception during the study and for 3 months after study completion, for female participants. Females with reproductive potential must have a negative urine or serum pregnancy test within 7 days of study.
Willing to continue current therapy for cancer for the duration of the study
If with diabetes mellitus HgbA1C of <10%
Adequate bone marrow function ANC> 1000/mm3, platelets 50,000/mm3, hemoglobin, 8g/dl.
No active infections including known history of HIV or viral hepatitis.

Exclusion Criteria:

Esophageal Cancer
Individuals with hypertriglyceridemia
Life expectancy of less than 12 weeks
Alcohol consumption more than 3 drinks/day for men or 2 drinks/day for women.
Untreated endocrine problems
Severe Depression
Untreated endocrine problems, such as hypothyroidism. Gonadal dysfunction from a known primary endocrine dysfunction (e.g. Klinefelters syndrome, pituitary tumor, testicular neoplasms, testicular surgery.
Medications that impair sex hormone synthesis, secretion, or function (e.g. spironolactone, anti-estrogens, anabolic steroids and androgens.
Fish oils within 3 months prior to study entry.
Any infectious disease, such as HIV or viral hepatitis.
Vitamins in doses greater than the Recommended Daily Allowance (RDA)
Herbs in the month prior to study entry.
Only participation in other cachexia studies is prohibited.
Prothrombin Time INR > 2.5 on Coumadin and INR > 2.0 not on Coumadin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094562

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Adrian S. Dobs, MD, MHS

Johns Hopkins University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00094562 History of Changes
Other Study ID Numbers:	P50 AT000437, JHM - IRB # 03-02-10-12
Study First Received:	October 20, 2004
Last Updated:	April 21, 2008
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Cancer
Cancer Cachexia
Weight Loss

Chronic Obstructive Pulmonary Disease
Chronic Heart Failure
Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Body Weight
Cachexia
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Weight Loss
Lung Diseases, Obstructive
Joint Diseases

Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Emaciation
Body Weight Changes
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012