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
Results First Received: September 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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
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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
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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  
Number of Participants  
[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  
Gender  
[units: participants]
       
Female     30     31     31     92  
Male     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     30     31     31     92  
More than one race     0     0     0     0  
Unknown or Not Reported     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

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:   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 ]
Results not yet posted.   Anticipated Posting Date:   10/2012   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


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