Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003077
Recruitment Status : Completed
First Posted : October 22, 2003
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight.

PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Dietary Supplement: omega-3 fatty acid Phase 1 Phase 2

Detailed Description:

OBJECTIVES:

  • Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients with cachexia.
  • Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients (phase I completed 12/1999).
  • Determine whether omega-3 fatty acids will result in an antitumor response.

OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by the extent of weight loss (2-5 percent or greater than 5 percent in the past month).

Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch for 4 months or until weight loss is observed.

Dose is escalated in cohorts of two patients, although dose escalation is allowed in individual patients. The maximum tolerated dose (MTD) is defined as the highest dose level at which no greater than one-third of the patients treated, including escalated patients from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
Study Start Date : October 1995
Actual Primary Completion Date : July 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Omega-3 fatty acid

Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch for 4 months or until weight loss is observed.

Dose is escalated in cohorts of two patients, although dose escalation is allowed in individual patients. Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period, patients will be discontinued from study. Patients will be followed for survival post-treatment.

 Dietary Supplement: omega-3 fatty acid


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. survival [ Time Frame: up to 4 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven advanced cancer not amenable to curative therapy (solid tumors and hematologic malignancies eligible except primary and metastatic brain tumors)
  • Cachexia (weight loss at least 2 percent within a one month period)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance Status:

  • CALBG 0-2

Life Expectancy:

  • At least 2 months

Hematopoietic:

  • Granulocytes greater than 1,000/mm3
  • Platelet count greater than 75,000/mm3
  • Hemoglobin greater than 8 mg/dL

Hepatic:

  • AST less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 3 times ULN
  • Bilirubin less than 1.5 times ULN

Renal:

  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No congestive heart failure requiring diuretics within less than 6 months
  • No uncontrolled or severe cardiovascular disease within less than 6 months
  • No myocardial infarction within less than 6 months

Other:

  • Not pregnant nor contemplating pregnancy during study
  • Negative pregnancy test
  • No uncontrolled hypercalcemia
  • No metabolic disorders (hyperthyroidism)
  • No poorly controlled diabetes
  • No peripheral edema or ascites requiring diuretics
  • No enteric fistulas, with tracheobronchial fistulas or with aspiration
  • No esophageal or bowel obstruction that would preclude eating
  • Free T4 within normal range
  • No serious medical illness
  • No psychosis
  • No uncontrolled bacterial, viral, or fungal infections
  • No active uncontrolled duodenal ulcers
  • Above laboratory values required unless bone marrow, liver, kidney, or splenic involvement by tumor is documented

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior and concurrent chemotherapy allowed

Endocrine therapy:

  • No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal failure)

Radiotherapy:

  • No prior or concurrent radiotherapy to abdomen or pelvis

Surgery:

  • Greater than 3 weeks since major surgery
  • Greater than 1 week since minor surgery

Other:

  • No concurrent diuretics
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003077


Locations
Layout table for location information
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: C. Patrick Burns, MD Holden Comprehensive Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003077    
Other Study ID Numbers: CALGB-9473
U10CA031946 ( U.S. NIH Grant/Contract )
CLB-9473
NCI-P97-0097
CDR0000065766 ( Registry Identifier: NCI Physician Data Query )
First Posted: October 22, 2003    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases