Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081965
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2004-04-27
Brief Title:
Acupuncture in Treating Hot Flashes in Women With Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-12
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 Acupuncture may help relieve hot flashes in women with breast cancer It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer
PURPOSE This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether acupuncture compared to placebo reduces the incidence of hot flashes in women with breast cancer
Secondary
Determine the long-term effects of acupuncture on hot flashes
OUTLINE This a randomized placebo-controlled multicenter study Patients are stratified according to concurrent treatment with selective estrogen receptor modulators gonadotropin-releasing hormone analogs or aromatase inhibitors yes vs no concurrent use of hot flash medication or selective serotonin reuptake inhibitors SSRIs yes vs no baseline hot flash frequency 7 per day and menopausal status at diagnosis premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
Arm I treatment Patients receive 8 acupuncture treatments over 4 weeks
Arm II control Patients receive 8 placebo acupuncture treatments over 4 weeks Beginning at week 7 patients are offered 8 true acupuncture treatments over 4 weeks
Patients in both arms complete a hot flash diary for 1 week before treatment and then periodically during and after treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Determine whether acupuncture compared to placebo reduces the incidence of hot flashes in women with breast cancer
Secondary
Determine the long-term effects of acupuncture on hot flashes
OUTLINE This a randomized placebo-controlled multicenter study Patients are stratified according to concurrent treatment with selective estrogen receptor modulators gonadotropin-releasing hormone analogs or aromatase inhibitors yes vs no concurrent use of hot flash medication or selective serotonin reuptake inhibitors SSRIs yes vs no baseline hot flash frequency 7 per day and menopausal status at diagnosis premenopausal vs postmenopausal Patients are randomized to 1 of 2 treatment arms
Arm I treatment Patients receive 8 acupuncture treatments over 4 weeks
Arm II control Patients receive 8 placebo acupuncture treatments over 4 weeks Beginning at week 7 patients are offered 8 true acupuncture treatments over 4 weeks
Patients in both arms complete a hot flash diary for 1 week before treatment and then periodically during and after treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-02108A | None | None | None |