Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005975
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2000-07-05
Brief Title:
S9626 Megestrol in Treating Hot Flashes Following Treatment for Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of Placebo Versus Megestrol Acetate 20 MGDay Versus Megestrol Acetate 40 MGDay as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer SWOG Study S9626
Status:
COMPLETED
Status Verified Date:
2015-11
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 may be effective in treating hot flashes following treatment for breast cancer It is not yet known which regimen of megestrol is most effective for hot flashes
PURPOSE Randomized phase III trial to compare the effectiveness of different doses of megestrol in treating hot flashes in patients who have undergone therapy for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different doses of megestrol in treating hot flashes in patients who have undergone therapy for breast cancer
Detailed Description:
OBJECTIVES I Compare the effectiveness and duration of the benefit of placebo versus low dose megestrol versus high dose megestrol in the reduction of severe andor frequent hot flashes in patients with previously treated invasive breast cancer II Document the effects of various dose levels of megestrol on atrophic vaginitis and dyspareunia in these patients III Evaluate the toxicity of this treatment in these patients
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to tamoxifen use yes vs no number of hot flashes per week 5-34 vs 35-63 vs more than 63 and duration of hot flashes 6 months or less vs longer than 6 months Patients are randomized to one of three treatment arms Arm I Patients receive oral placebo daily Arm II Patients receive lower dose oral megestrol daily Arm III Patients receive higher dose oral megestrol daily Patients who do not respond after 3 months of treatment receive an additional dose of oral megestrol daily Treatment continues for a total of 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 3 months
PROJECTED ACCRUAL A total of 279 eligible patients 93 per arm are expected to be accrued
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to tamoxifen use yes vs no number of hot flashes per week 5-34 vs 35-63 vs more than 63 and duration of hot flashes 6 months or less vs longer than 6 months Patients are randomized to one of three treatment arms Arm I Patients receive oral placebo daily Arm II Patients receive lower dose oral megestrol daily Arm III Patients receive higher dose oral megestrol daily Patients who do not respond after 3 months of treatment receive an additional dose of oral megestrol daily Treatment continues for a total of 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 3 months
PROJECTED ACCRUAL A total of 279 eligible patients 93 per arm are expected to be accrued
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 |
|---|---|---|---|
| U10CA037429 | NIH | NCI | httpsreporternihgovquickSearchU10CA037429 |
| S9626 | OTHER | None | None |
| NCI-P00-0159 | OTHER | None | None |