Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060320
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-05-06
Brief Title:
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Double-Blind Randomized Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
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 The herbal supplement black cohosh may be effective in relieving hot flashes in women
PURPOSE Randomized phase III trial to determine the effectiveness of black cohosh in relieving hot flashes in women who have breast cancer or who are at risk of developing breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of black cohosh in relieving hot flashes in women who have breast cancer or who are at risk of developing breast cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of black cohosh vs placebo in diminishing hot flash activity in women with breast cancer OR a concern about taking hormones because of a fear of breast cancer
Determine whether continued use of this drug by these patients leads to prolonged reduction of the hot flash score with minimal toxic effects
Correlate the reduction of hot flash score with improvement in quality of life and related outcomes in patients treated with this drug
Determine the toxic effects of this drug in these patients
Determine whether abnormal sweating is decreased in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled crossover study Patients are stratified according to age 18 to 49 vs 50 and over current tamoxifen use yes vs no vs unknown current raloxifene use yes vs no vs unknown current aromatase inhibitor use yes vs no duration of hot flash symptoms less than 9 months vs 9 months or more and average frequency of hot flashes per day 2-3 vs 4-9 vs 10 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral black cohosh twice daily for 4 weeks
Arm II Patients receive oral placebo twice daily for 4 weeks All patients then cross over to the other arm and receive treatment as above for 4 weeks
After completion of the crossover treatment all patients may opt to receive open-label black cohosh for an additional 8 weeks
Patients complete a hot flash diary daily at baseline and during the 8-week double-blind study and then daily for 8 weeks during optional open-label treatment
Patients who opt to receive open-label black cohosh are followed at 6 months 1 year and 2 years
PROJECTED ACCRUAL A total of 110 patients 55 patients per arm will be accrued for this study within 6-11 months
Compare the efficacy of black cohosh vs placebo in diminishing hot flash activity in women with breast cancer OR a concern about taking hormones because of a fear of breast cancer
Determine whether continued use of this drug by these patients leads to prolonged reduction of the hot flash score with minimal toxic effects
Correlate the reduction of hot flash score with improvement in quality of life and related outcomes in patients treated with this drug
Determine the toxic effects of this drug in these patients
Determine whether abnormal sweating is decreased in patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled crossover study Patients are stratified according to age 18 to 49 vs 50 and over current tamoxifen use yes vs no vs unknown current raloxifene use yes vs no vs unknown current aromatase inhibitor use yes vs no duration of hot flash symptoms less than 9 months vs 9 months or more and average frequency of hot flashes per day 2-3 vs 4-9 vs 10 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral black cohosh twice daily for 4 weeks
Arm II Patients receive oral placebo twice daily for 4 weeks All patients then cross over to the other arm and receive treatment as above for 4 weeks
After completion of the crossover treatment all patients may opt to receive open-label black cohosh for an additional 8 weeks
Patients complete a hot flash diary daily at baseline and during the 8-week double-blind study and then daily for 8 weeks during optional open-label treatment
Patients who opt to receive open-label black cohosh are followed at 6 months 1 year and 2 years
PROJECTED ACCRUAL A total of 110 patients 55 patients per arm will be accrued for this study within 6-11 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 |
|---|---|---|---|
| CDR0000301615 | REGISTRY | PDQ Physician Data Query | None |