Clinical trial NCT00569166: Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Official title: Paced Breathing for Hot Flashes: A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Hot Flashes
Sleep Disorders
Keywords: fatigue
sleep disorders
ductal breast carcinoma in situ
lobular breast carcinoma in situ
breast cancer
hot flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-06
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9
timeFrame: Week 1 and Week 9
Secondary outcomes:
measure: Change From Baseline to Week 9 for PSQI Global Score
timeFrame: Baseline and Week 9
measure: Change From Baseline to Week 9 on Blood Pressure Measurement
timeFrame: Baseline and Week 9
measure: Change From Baseline to Week 9 for POMS Total Score and Subscales
timeFrame: Baseline and Week 9
measure: 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
timeFrame: Baseline and Week 9
measure: Change From Baseline to Week 9 for BFI Fatigue Scores
timeFrame: Baseline and Week 9
measure: Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9
timeFrame: Baseline and Week 9
measure: Change From Baseline to Week 9 for Symptom Distress Diary
timeFrame: Baseline and Week 9
measure: 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
timeFrame: Baseline and Week 9
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amit Sood, MD
role: STUDY_CHAIR
References: