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Fish oil supplement

Adrian S. Dobs, MD, MHS

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.

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

AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss

National Center for Complementary and Integrative Health (NCCIH)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Lycopene

Antioxidants

Protective Agents

Radiation-Protective Agents

Omega 3 Fatty Acid

Two 15mg lycopene capsules daily for 3 months.

lycopene supplement

fish oil supplement

Placebo

Peter R. Carroll, MD

RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer.

OBJECTIVES:

Primary

* Compare gene expression in normal prostate tissue (at baseline and after treatment) of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo.

Secondary

* Determine new candidate molecular targets for lycopene and omega-3 response pathways.
* Correlate baseline gene expression patterns, determined by cDNA array analysis, with self-reported dietary intake.
* Correlate gene expression patterns with progression or lack of progression at 12 months after study entry.
* Determine if lycopene or omega-3 supplements affect the incidence of tumor progression.

OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to dietary intake of tomato and fish (low tomato \[\< 4 servings/week\], low fish \[\< 2 servings/week\] vs low tomato, high fish \[≥ 2 servings/week\] vs high tomato \[≥ 4 servings/week\], low fish vs high tomato, high fish). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients maintain normal diet and receive oral omega-3 fatty acids placebo 3 times daily and lycopene placebo twice daily.
* Arm II: Patients receive oral lycopene twice daily and oral omega-3 fatty acids placebo 3 times daily.
* Arm III: Patients receive oral lycopene placebo twice daily and oral omega-3 fatty acids 3 times daily.

In all arms, treatment continues for up to 90 days or until post-treatment biopsy is scheduled (a maximum of 104 days) in the absence of disease progression.

Patients complete a dietary questionnaire at baseline and then for 3 days each month during study therapy. Quality of life is assessed at baseline and at 3 months.

Prostate tissue needle biopsies and blood samples are collected at baseline and at 3 months. Tissue and blood samples are examined for lycopene and omega-3 fatty acids (treatment compliance), omega-6 fatty acids, insulin-like growth factor (IGF)-1, IGF binding protein-5, and cyclooxygenase-2 gene by polymerase chain reaction, cDNA microarray hybridization, and other gene expression assays.

After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 114 patients will be enrolled in this study.

Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer

The Molecular Effects of Nutrition Supplements (MENS) Prostate Study

Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.

National Cancer Institute (NCI)

University of California, San Francisco

All Participants

two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene \& placebo for fish oil.

Lycopene Supplement

three 1g fish oil capsules daily including 1,098mg EPA \& 549mg DHA fatty acid (Roche).

men took fish oil \& placebo for lycopene.

Fish Oil Supplement

men took placebo for lycopene \& placebo for fish oil.

Total

Age, Continuous

Sex: Female, Male

Peter Carroll, MD

IGF-1

COX-2

IGF-1R

1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.

Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss	NCT00094562	Cancer Cancer Cachexia Chronic Obstruc... Chronic Heart F... Rheumatoid Arth...	Fish oil supple...	18 Years - 90 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer	NCT00402285	Prostate Cancer	lycopene supple... fish oil supple... Placebo	-	University of California, San Francisco
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss	NCT00094562	Cancer Cancer Cachexia Chronic Obstruc... Chronic Heart F... Rheumatoid Arth...	Fish oil supple...	18 Years - 90 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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