CancerPhase 2NCT00094562
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
A Phase 2 study testing Fish oil supplement in people with Cancer and Cancer Cachexia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Cancer Cachexia, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Fish oil supplement
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AAFA™ Fish Oil Nutritional Supplementation 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.
Read the 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.
- Conditions
- Cancer, Cancer Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure, Rheumatoid Arthritis
- Being tested
- Fish oil supplement
- Keywords
- Cancer, Cancer Cachexia, Weight Loss, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure, Rheumatoid Arthritis
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Arthritis, Rheumatoid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil supplementDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
lean body mass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2004 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Adrian S. Dobs, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094562
- Sponsor's protocol ID
- J0275
- Other IDs
- 03-02-10-12, P50AT000437
- Status last verified
- Apr 2008
- First submitted
- 20 Oct 2004
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss
- ClinicalTrials.gov ID
- NCT00094562
- Acronym / sponsor ID
- J0275
- Conditions
- Cancer, Cancer Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure, Rheumatoid Arthritis
- Keywords
- Cancer, Cancer Cachexia, Weight Loss, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil supplement | Drug | – |
Primary outcome
Body weight
lean body mass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian S. Dobs, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish oil supplement in people with Cancer and Cancer Cachexia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.