Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 2:03 PM
Study NCT ID:
NCT00569166
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Paced Breathing for Hot Flashes: A Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2011-11
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: Paced breathing may be an effective way to reduce the number and severity of hot flashes in women who have survived breast cancer.
PURPOSE: This randomized phase II trial is comparing three different programs of paced breathing to see how well they work in treating hot flashes in women.
PURPOSE: This randomized phase II trial is comparing three different programs of paced breathing to see how well they work in treating hot flashes in women.
Detailed Description:
OBJECTIVES:
* To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing (15 minutes once a day at 6 breaths/minute vs 15 minutes twice a day at 6 breaths/minute vs 10 minutes once a day at 14 breaths/minute) on the frequency and severity of hot flashes in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
* To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing on mood states, fatigue, sleep quality, and blood pressure measurement in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
OUTLINE: Patients are stratified by age (18-49 vs ≥ 50), frequency of hot flashes per day (\< 4 vs 4-9 vs ≥ 10), and current tamoxifen, raloxifene, or aromatase inhibitor treatment (yes vs no). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
* Arm II: Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
* Arm III: Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
All patients complete daily hot flash diaries, keep a blood pressure log, and complete the following questionnaires: Symptom Experience Diary, Profile of Mood States, Brief Fatigue Inventory, and Pittsburgh Sleep Quality Index.
* To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing (15 minutes once a day at 6 breaths/minute vs 15 minutes twice a day at 6 breaths/minute vs 10 minutes once a day at 14 breaths/minute) on the frequency and severity of hot flashes in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
* To assess feasibility and obtain initial estimates of efficacy of three different programs of paced breathing on mood states, fatigue, sleep quality, and blood pressure measurement in breast cancer survivors or patients not preferring to take hormones because of concern for breast cancer.
OUTLINE: Patients are stratified by age (18-49 vs ≥ 50), frequency of hot flashes per day (\< 4 vs 4-9 vs ≥ 10), and current tamoxifen, raloxifene, or aromatase inhibitor treatment (yes vs no). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
* Arm II: Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
* Arm III: Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
All patients complete daily hot flash diaries, keep a blood pressure log, and complete the following questionnaires: Symptom Experience Diary, Profile of Mood States, Brief Fatigue Inventory, and Pittsburgh Sleep Quality Index.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| MC06C8 | OTHER | Mayo Clinic Cancer Center | View | |
| 06-005157 | OTHER | Mayo Clinic IRB | View |