Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026286
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2001-11-09
Brief Title:
Hormone Replacement Therapy for Hot Flashes andor Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase III Prospective Randomized Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
Status:
COMPLETED
Status Verified Date:
2023-06
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 Hormone replacement therapy may be effective in managing the hot flashes andor vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes andor vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes andor vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen
Determine the effect of this regimen on blood coagulation and lipid profiles in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior hysterectomy yes vs no symptom complex vasomotor vs vaginal vs both duration of hot flashes less than 1 year or no hot flashes vs 1 year or more and average daily number of hot flashes less than 10 or none vs 10 or more Patients are randomized to one of two treatment arms
Arm I Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months If after 1 month symptoms do not resolve patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months
Arm II Patients receive oral placebo once daily for 6 months Quality of life is assessed at baseline and months 1 2 3 and 6
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 120 patients 60 per treatment arm will be accrued for this study within 12 months
Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen
Determine the effect of this regimen on blood coagulation and lipid profiles in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior hysterectomy yes vs no symptom complex vasomotor vs vaginal vs both duration of hot flashes less than 1 year or no hot flashes vs 1 year or more and average daily number of hot flashes less than 10 or none vs 10 or more Patients are randomized to one of two treatment arms
Arm I Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months If after 1 month symptoms do not resolve patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months
Arm II Patients receive oral placebo once daily for 6 months Quality of life is assessed at baseline and months 1 2 3 and 6
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 120 patients 60 per treatment arm will be accrued for this study within 12 months
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-P01-0194 | None | None | None |
| E-2193 | None | None | None |