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

Mayo Clinic

Status: Completed

Conditions: Sleep Disorders; Breast Cancer; Hot Flashes; Fatigue

Treatments: Behavioral: 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)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00569166

P30CA015083 (U.S. NIH Grant/Contract)

CDR0000579010

MC06C8 (Other Identifier)

06-005157 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups, including a placebo group

Paced breathing (15 min once daily, 6 breaths/min)

Active Comparator group

Description:

Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Treatment:

Behavioral: Paced breathing (15 min once daily, 6 breaths/min)

Paced breathing (15 min twice daily, 6 breaths/min)

Active Comparator group

Description:

Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Treatment:

Behavioral: Paced breathing (15 min twice daily, 6 breaths/min)

Paced breathing (10 min once daily, 14 breaths/min)

Placebo Comparator group

Description:

Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Treatment:

Behavioral: Paced breathing (10 min once daily, 14 breaths/min)