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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

December 5, 2007
November 1, 2011
March 2007
February 2010   (final data collection date for primary outcome measure)
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.
  • Change in hot flash score
  • Feasibility
  • Compliance with intervention
Complete list of historical versions of study NCT00569166 on ClinicalTrials.gov Archive Site
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 ]
Adverse events, 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
Not Provided
Not Provided
 
Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Paced Breathing for Hot Flashes: A Randomized Phase II Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Fatigue
  • Hot Flashes
  • Sleep Disorders
  • 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.
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Paced breathing (15 min once daily, 6 breaths/min)
  • 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.
    Intervention: Behavioral: Paced breathing (15 min twice daily, 6 breaths/min)
  • 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.
    Intervention: Behavioral: Paced breathing (10 min once daily, 14 breaths/min)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
Not Provided
February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569166
CDR0000579010, P30CA015083, MC06C8, 06-005157
Not Provided
Amit Sood, Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Amit Sood, MD Mayo Clinic
Mayo Clinic
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP