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
3 other identifiers
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 cancer
Started Jun 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 20, 2004
CompletedFirst Posted
Study publicly available on registry
October 21, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 18, 2019
April 1, 2008
3.3 years
October 20, 2004
January 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Body weight
lean body mass
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian S. Dobs, MD, MHS
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2004
First Posted
October 21, 2004
Study Start
June 1, 2004
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
January 18, 2019
Record last verified: 2008-04