CompletedPhase 2NCT00094562

A Fish Oil Supplement 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.

Checked against the public recordLast updated Jan 18, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Drug: Fish oil supplement
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Johns Hopkins HospitalBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2019. Always confirm current availability with the study team.

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