Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031707
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2002-03-08
Brief Title:
Comparison of Megestrol andor Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Double-Blind Placebo-Controlled Randomized Comparison of Megestrol Acetate Megace Versus an N-3 Fatty Acid EPA Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia
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 Megestrol and or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite It is not yet known whether megestrol alone an omega-3 fatty acid-enriched nutritional supplement alone or a combination of both is most effective in treating cancer-related weight loss and loss of appetite
PURPOSE Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite
PURPOSE Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite
Detailed Description:
OBJECTIVES
Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both in terms of patient weight rate of weight change and appetite in patients with cancer-related cachexia and anorexia
Determine the effect of these regimens on nausea and vomiting in these patients
Assess quality of life in patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Compare overall survival of patients treated with these regimens
Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to primary cancer lung vs gastrointestinal vs other severity of weight loss in the past 2 months less than 10 pounds vs 10 pounds or more planned concurrent chemotherapy yes vs no age under 50 vs 50 and over and prognosis good vs bad vs unsure Patients are randomized to 1 of 3 treatment arms
Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both in terms of patient weight rate of weight change and appetite in patients with cancer-related cachexia and anorexia
Determine the effect of these regimens on nausea and vomiting in these patients
Assess quality of life in patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Compare overall survival of patients treated with these regimens
Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to primary cancer lung vs gastrointestinal vs other severity of weight loss in the past 2 months less than 10 pounds vs 10 pounds or more planned concurrent chemotherapy yes vs no age under 50 vs 50 and over and prognosis good vs bad vs unsure Patients are randomized to 1 of 3 treatment arms
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 |
|---|---|---|---|
| NCI-P02-0205 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069218 | REGISTRY | None | None |
| CAN-NCIC-SC18 | None | None | None |