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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569166
First Posted: December 6, 2007
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  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
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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:
  • Change From Baseline to Week 9 for PSQI Global Score [ Time Frame: Baseline and Week 9 ]
    The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.

  • Change From Baseline to Week 9 on Blood Pressure Measurement [ Time Frame: Baseline and Week 9 ]
    Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9.

  • Change From Baseline to Week 9 for POMS Total Score and Subscales [ Time Frame: Baseline and Week 9 ]
    Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.

  • 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 [ Time Frame: Baseline and Week 9 ]
    Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores.

  • Change From Baseline to Week 9 for BFI Fatigue Scores [ Time Frame: Baseline and Week 9 ]
    Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.

  • Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9 [ Time Frame: Baseline and Week 9 ]
    Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores.

  • Change From Baseline to Week 9 for Symptom Distress Diary [ Time Frame: Baseline and Week 9 ]
    Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.

  • 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 [ Time Frame: Baseline and Week 9 ]
    Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores.


Enrollment: 105
Study Start Date: March 2007
Study Completion Date: May 14, 2012
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569166


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

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00569166     History of Changes
Other Study ID Numbers: CDR0000579010
P30CA015083 ( U.S. NIH Grant/Contract )
MC06C8 ( Other Identifier: Mayo Clinic Cancer Center )
06-005157 ( Other Identifier: Mayo Clinic IRB )
First Submitted: December 5, 2007
First Posted: December 6, 2007
Results First Submitted: September 13, 2011
Results First Posted: December 6, 2011
Last Update Posted: August 7, 2017
Last Verified: November 2011

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:
Fatigue
Sleep Wake Disorders
Parasomnias
Hot Flashes
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders