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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00569166

First received: December 5, 2007

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

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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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 ]

Show Outcome Measure 1

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

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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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

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