Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070148
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2003-10-03
Brief Title:
Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Randomized Study Comparing The Effects Of Oxandrolone Oxandrin And Megestrol Acetate Megace On Lean Body Mass Weight Body Fat And Quality Of Life In Patients With Solid Tumors And Weight Loss Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2021-09
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 Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors
PURPOSE This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors
PURPOSE This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors
Detailed Description:
OBJECTIVES
Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol
Compare the health-related quality of life of patients treated with these drugs
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage I-III vs IV concurrent radiotherapy yes vs no and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral oxandrolone twice daily
Arm II Patients receive oral megestrol once daily In both arms treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity
Quality of life weight and body composition are assessed at baseline at 1 2 and 3 months during study therapy and then at 1 month after study completion
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 62-155 patients 31-77 per treatment arm will be accrued for this study within 2 years
Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol
Compare the health-related quality of life of patients treated with these drugs
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage I-III vs IV concurrent radiotherapy yes vs no and gender Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral oxandrolone twice daily
Arm II Patients receive oral megestrol once daily In both arms treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity
Quality of life weight and body composition are assessed at baseline at 1 2 and 3 months during study therapy and then at 1 month after study completion
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 62-155 patients 31-77 per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| REBACCCWFU97102 | OTHER | NCI | httpsreporternihgovquickSearchU10CA081851 |
| U10CA081851 | NIH | None | None |