N/A
N=218
Breathe for Hot Flashes Randomized Controlled Trial
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT00819182 ↗Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Hot Flash Frequency — 3.48; 3.95; 4.76 Hot flashes per 24 hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Paced respiration (Behavioral); Sham comparator: fast shallow breathing (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hot Flash Frequency |
3.48; 3.95; 4.76 | — |
| PRIMARY Hot Flash Severity |
4.33; 4.65; 5.20 | — |
| PRIMARY Hot Flash Bother |
3.89; 4.22; 4.76 | — |
| SECONDARY Hot Flash Related Daily Interference |
2.75; 3.41; 3.93 | — |
| SECONDARY Perceived Control Over Hot Flashes |
42.67; 42.69; 39.60 | — |
| SECONDARY Mood Disturbance |
38.26; 40.13; 43.48 | — |
| SECONDARY Sleep Disturbance |
6.81; 7.66; 8.23 | — |
Summary
Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence.
Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms.
Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.
Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries.
Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.
Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Reporting daily hot flashes and desirous of hot flash treatment
- Peri- or post menopausal
- Living within a 60-mile radius of Indianapolis or willing to drive to the center for all study visits
- Able to read, write, and speak English
- in good general health
In addition:
- Breast Cancer survivors will have a known diagnosis of non-metastatic disease
- No history of other cancers
- Be at least four weeks post-completion of surgery, radiation and chemotherapy
Exclusion Criteria
- Known psychiatric disorders or cognitive impairments
- Participation in our previous pilot study evaluating our control condition
- Self-reported difficulties with normal everyday breathing
- Meet criteria at baseline for number of subjective and/or objective hot flashes
Data sourced from ClinicalTrials.gov (NCT00819182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.