N/A N=92 Randomized Single-blind Supportive Care

Three Different Programs of Paced Breathing in Treating Hot Flashes in Women

Breast Cancer · Fatigue · Hot Flashes · Sleep Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00569166 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcome: Primary: The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 — -6.5; -7.5; -6.5 units on a scale — p=0.3679

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paced breathing (15 min once daily, 6 breaths/min) (Behavioral); Paced breathing (15 min twice daily, 6 breaths/min) (Behavioral); Paced breathing (10 min once daily, 14 breaths/min) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Mayo Clinic
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9	-6.5; -7.5; -6.5	0.3679
SECONDARY Change From Baseline to Week 9 for PSQI Global Score	4.8; 4.8; 7.1	—
SECONDARY Change From Baseline to Week 9 on Blood Pressure Measurement	-4.1; -1.9; -1.6; -2.1; -1.7; 0.5	—
SECONDARY Change From Baseline to Week 9 for POMS Total Score and Subscales	4.4; 5.2; 3.9; 0; 5; 3	—
SECONDARY Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9	-0.05; -0.32; 0.29; -0.18; -0.36; 0.19	—
SECONDARY Change From Baseline to Week 9 for BFI Fatigue Scores	8.9; 13.5; 17.2; 16.3; 11.8; 12.4	—
SECONDARY Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9	-0.25; -0.20; -0.18; 0.13; 0.06; -0.12	—
SECONDARY Change From Baseline to Week 9 for Symptom Distress Diary	15.3; 20.8; 17.2; 20.0; 24.6; 29.2	—
SECONDARY Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9	-0.24; 0.04; 0.26; -0.43; -0.30; -0.20	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00569166). 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.