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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00569166
First received: December 5, 2007
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Fatigue
Hot Flashes
Sleep Disorders
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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Paced Breathing for Hot Flashes: A Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9 [ Time Frame: Week 1 and Week 9 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: March 2007
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
Behavioral: 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.
Placebo Comparator: 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.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569166

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Amit Sood, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Amit Sood, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00569166     History of Changes
Other Study ID Numbers: CDR0000579010, P30CA015083, MC06C8, 06-005157
Study First Received: December 5, 2007
Results First Received: September 13, 2011
Last Updated: November 1, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
fatigue
sleep disorders
ductal breast carcinoma in situ
lobular breast carcinoma in situ
breast cancer
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Sleep Disorders
Parasomnias
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014