Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003077
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Trial of Omega-3 Fatty Acids for Cancer Cachexia
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss
PURPOSE Phase III 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 121999
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 withafter 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 121999
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 121999
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 withafter 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 121999
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065766 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9473 | None | None | None |
| NCI-P97-0097 | None | None | None |