Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
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.
Multiple Myeloma and Plasma Cell Neoplasm
Dietary Supplement: omega-3 fatty acid
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia|
|Study Start Date:||October 1995|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
- 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).
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.
PROJECTED ACCRUAL: A total of 57-63 patients will be enrolled in the Phase I and II study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003077
|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|
|Study Chair:||C. Patrick Burns, MD||Holden Comprehensive Cancer Center|