Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006799
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2000-12-06
Brief Title:
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Double-Blind Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy
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 Megestrol helps improve appetite It is not yet known if megestrol is effective in limiting weight loss caused by cancer
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy
Detailed Description:
OBJECTIVES
Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy
Determine whether health-related quality of life improves in patients treated with megestrol
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to type of treatment radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy and type of radiotherapy primary vs postoperative Patients are randomized to one of two treatment arms
Arm I Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy
Arm II Patients receive oral placebo daily according to the schedule for megestrol in arm I
Quality of life is assessed at baseline at completion of radiotherapy and then at 4 8 12 and 16 weeks after completion of radiotherapy
PROJECTED ACCRUAL A total of 48-144 patients 24-72 per arm will be accrued for this study within 14 months
Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy
Determine whether health-related quality of life improves in patients treated with megestrol
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to type of treatment radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy and type of radiotherapy primary vs postoperative Patients are randomized to one of two treatment arms
Arm I Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy
Arm II Patients receive oral placebo daily according to the schedule for megestrol in arm I
Quality of life is assessed at baseline at completion of radiotherapy and then at 4 8 12 and 16 weeks after completion of radiotherapy
PROJECTED ACCRUAL A total of 48-144 patients 24-72 per arm will be accrued for this study within 14 months
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 |
|---|---|---|---|
| CCCWFU-97300 | None | None | None |
| CCCWFU-0009 | None | None | None |
| CCCWFU-BG00-228 | None | None | None |
| NCI-P00-0174 | None | None | None |