Paced Breathing for Hot Flashes: A Randomized Phase II Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9
Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.
Week 1 and Week 9
No
Amit Sood, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000579010
NCT00569166
March 2007
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |