Clinical trial · Interventional
Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Paced Breathing for Hot Flashes: A Randomized Phase II Study
NCT00569166CI-TRIAL-00028957completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paced breathing (10 min once daily, 14 breaths/min) | Behavioral | — | UNRESOLVED |
| Paced breathing (15 min once daily, 6 breaths/min) | Behavioral | — | UNRESOLVED |
| Paced breathing (15 min twice daily, 6 breaths/min) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Paced breathing (15 min once daily, 6 breaths/min)
- description
- Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
- interventionNames
- Behavioral: Paced breathing (15 min once daily, 6 breaths/min)
- type
- ACTIVE_COMPARATOR
- label
- Paced breathing (15 min twice daily, 6 breaths/min)
- description
- Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
- interventionNames
- Behavioral: Paced breathing (15 min twice daily, 6 breaths/min)
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of breast cancer including ductal carcinoma in situ or lobular carcinoma in situ \- Treated with surgery and/or adjuvant therapy with a curative intent or patients not preferring to take hormones because of concern for breast cancer * Frequent hot flashes (≥ 14 per week) of sufficient severity to make the patient desire treatment * Presence of hot flashes for ≥ 1 month prior to study entry * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Pre- or post-menopausal * Must possess a compact disc (CD) player * Able to complete questionnaires alone or with assistance * No active medical conditions preventing compliance with a practice of slow deep breathing including active asthma, chronic obstructive pulmonary disease, or congestive heart failure * No uncontrolled hypertension (defined as systolic blood pressure (BP) ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg on 2 separate visits) PRIOR CONCURRENT THERAPY: * No current (within the past month) practice of yoga or breathing exercises * No other concurrent agents for treating hot flashes (e.g., gabapentin, venlafaxine, paroxetine, citalopram, sertraline, natural products such as soy or sage supplements, flaxseed, or black cohosh) \- Concurrent stable dose antidepressants started within the past 30 days allowed * No concurrent hormonal agents and/or antineoplastic chemotherapy - Tamoxifen, raloxifene, and aromatase inhibitors are allowed if patient has been on a constant dose for ≥ 4 weeks and does not plan to stop the treatment during the course of the study
References
Publications (0)
Data not yet available
No reference posted for this study.