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About
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.
Full 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).
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63 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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