We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Results First Submitted: September 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Fatigue
Hot Flashes
Sleep Disorders
Interventions: 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)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One-hundred and five (105) participants were recruited at Mayo Clinic Rochester between 3/08/2007 and 12/8/2009. There were 13 cancelled participants and were excluded from baseline characteristics table.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were evaluated by telephone, or in person, according to the eligibility criteria and educated about the requirements of the study. Eligible and willing women were registered onto the study.

Reporting Groups
  Description
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 compact disc (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 compact disc (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 compact disc (CD), for 8 weeks.

Participant Flow:   Overall Study
    Paced Breathing (15 Min Once Daily, 6 Breaths/Min)   Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)   Paced Breathing (10 Min Once Daily, 14 Breaths/Min)
STARTED   30   31   31 
COMPLETED   21   25   27 
NOT COMPLETED   9   6   4 
Withdrawal by Subject                7                5                3 
Lost to Follow-up                2                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 compact disc (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 compact disc (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 compact disc (CD), for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Paced Breathing (15 Min Once Daily, 6 Breaths/Min)   Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)   Paced Breathing (10 Min Once Daily, 14 Breaths/Min)   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   31   31   92 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (8.4)   54.4  (8.1)   54.5  (8.7)   53.4  (8.5) 
Age, Customized 
[Units: Participants]
       
Between 18 and 49 years   15   8   9   32 
>=50 years   15   23   22   60 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      30 100.0%      31 100.0%      31 100.0%      92 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      30 100.0%      31 100.0%      31 100.0%      92 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   30   31   31   92 
Breast Cancer History 
[Units: Participants]
       
Yes   20   13   15   48 
No   10   18   16   44 
Average Frequency of Hot Flashes per day 
[Units: Participants]
       
<4 Hot flashes per day   1   2   6   9 
4-9 Hot flashes per day   10   15   14   39 
>=10 Hot flashes per day   19   14   11   44 
Current tamoxifen, raloxifene, or aromatase inhibitor treatment 
[Units: Participants]
       
Yes   14   7   12   33 
No   16   24   19   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9   [ Time Frame: Week 1 and Week 9 ]

2.  Secondary:   Change From Baseline to Week 9 for PSQI Global Score   [ Time Frame: Baseline and Week 9 ]

3.  Secondary:   Change From Baseline to Week 9 on Blood Pressure Measurement   [ Time Frame: Baseline and Week 9 ]

4.  Secondary:   Change From Baseline to Week 9 for POMS Total Score and Subscales   [ Time Frame: Baseline and Week 9 ]

5.  Secondary:   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 ]

6.  Secondary:   Change From Baseline to Week 9 for BFI Fatigue Scores   [ Time Frame: Baseline and Week 9 ]

7.  Secondary:   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 ]

8.  Secondary:   Change From Baseline to Week 9 for Symptom Distress Diary   [ Time Frame: Baseline and Week 9 ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Amit Sood
Organization: Mayo Clinic
phone: 507-538-7623 ext 8-7623
e-mail: sood.amit@mayo.edu



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