Clinical Trials Directory

Trials / Completed

CompletedNCT00003077

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

Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Not accepted

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.

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).

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTomega-3 fatty acid

Timeline

Start date
1995-10-01
Primary completion
2004-07-01
Completion
2004-11-01
First posted
2003-10-22
Last updated
2016-07-13

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00003077. Inclusion in this directory is not an endorsement.