Lymphoma Clinical Trial
Official title:
Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
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.
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).
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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