NCT00094562

CompletedPhase 2

A Fish Oil Supplement to Maintain Body Weight in Patients Wi...

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

J0275

Secondary identifiers

03-02-10-12

OTHER · JHM IRB

P50AT000437

NIH

Study Type

interventional

Actual enrollment (reported)

25

Locations

1 country

Sites

1

Timeline

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2007

Actual (reported)

Study Completion

September 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 25 participants
Study completion date: September 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 20, 2004
Actual (reported)
First Posted
October 21, 2004
Actual (reported)
Primary Completion
September 2007
Actual (reported)
Study Completion
September 2007
Actual (reported)

Last Updated: January 18, 2019
Status Verified: April 2008
Last Update Submitted: January 16, 2019

Conditions

Cancer Cancer Cachexia Chronic Heart Failure Chronic Obstructive Pulmonary Disease Rheumatoid Arthritis

Keywords

CancerCancer CachexiaWeight LossChronic Obstructive Pulmonary DiseaseChronic Heart FailureRheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

Body weight
lean body mass

Interventions

Fish oil supplementDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Otherlead
National Center for Complementary and Integrative Health (NCCIH)
NIHcollaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

MeSH Terms

Conditions

NeoplasmsPulmonary Disease, Chronic ObstructiveArthritis, RheumatoidWeight Loss

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

Adrian S. Dobs, MD, MHS
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Enrollment

25 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

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NCT00096083

Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer

Phase 2Completed

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.

Connective Tissue Diseases

Skin and Connective Tissue Diseases

Autoimmune Diseases

Immune System Diseases

Body Weight Changes

Body Weight

Signs and Symptoms

Primary Completion

September 2007

Actual (reported)

Study Completion

September 2007

Actual (reported)

Last Updated

January 18, 2019

Record last verified: 2008-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00094562
Data provider: ClinicalTrials.gov
Source updated: 2019-01-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:40 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations