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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFish oil supplement

The study team can explain what participation involves.

Who it may be forCancer · Cancer Cachexia

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study sponsor

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

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How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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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