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

Breast Cancer Clinical Trial

Official title:

Paced Breathing for Hot Flashes: A Randomized Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569166
• Other study ID #: CDR0000579010
• Secondary ID: P30CA015083MC06C
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: January 7, 2016
• Start date: March 2007

Study information

• Verified date: November 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue
• Hot Flashes
• Parasomnias
• Sleep Disorders

Intervention

Behavioral:
• Paced breathing (15 min once daily, 6 breaths/min)
Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
• Paced breathing (15 min twice daily, 6 breaths/min)
Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.
• Paced breathing (10 min once daily, 14 breaths/min)
Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9	Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.	Week 1 and Week 9	No
Secondary	Mood States, Fatigue, Sleep Quality, and Blood Pressure Measurements as Assessed by the Symptom Experience Diary, Profile of Mood States, Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, and Blood Pressure Log		5 weeks	No