Clinical trial · Interventional
Breathe for Hot Flashes Randomized Controlled Trial
Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paced respiration | Behavioral | — | UNRESOLVED |
| Sham comparator: fast shallow breathing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Paced respiration
- description
- The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations (4). They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies (5, 6). The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
- interventionNames
- Behavioral: Paced respiration
- type
- SHAM_COMPARATOR
- label
- Sham comparator: Fast, shallow breathing
- description
- The sham comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash. A previously published report provides additional details and data indicating this program was a suitable attention control.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTCarpenter JS, Burns DS, Wu J, Otte JL, Schneider B, Ryker K, Tallman E, Yu M. Paced respiration for vasomotor and other menopausal symptoms: a randomized, controlled trial. J Gen Intern Med. 2013 Feb;28(2):193-200. doi: 10.1007/s11606-012-2202-6. PMID 22936289