Three Different Programs of Paced Breathing in Treating Hot Flashes in Women - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00569166

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	Phase
Breast Cancer Fatigue Hot Flashes Sleep Disorders	Other: questionnaire administration Procedure: CAM exercise therapy Procedure: hot flashes attenuation Procedure: management of therapy complications	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind
Official Title:	Paced Breathing for Hot Flashes: A Randomized Phase II Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Sleep Disorders

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Change in hot flash score
Feasibility
Compliance with intervention

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	March 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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 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

Ages Eligible for Study:	18 Years and older
Genders 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:

ECOG performance status 0 or 1
Pre- or post-menopausal
Must possess a 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569166

Locations

United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Amit Sood, MD	Mayo Clinic
Investigator:	Debra Barton, RN, PhD, AOCN, FAAN	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic Cancer Center ( Amit Sood )
Study ID Numbers:	CDR0000579010, MAYO-MC06C8
Study First Received:	December 5, 2007
Last Updated:	November 21, 2009
ClinicalTrials.gov Identifier:	NCT00569166 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
sleep disorders
ductal breast carcinoma in situ

lobular breast carcinoma in situ
breast cancer
hot flashes

Additional relevant MeSH terms:

Disease
Fatigue
Skin Diseases
Nervous System Diseases
Hot Flashes
Breast Neoplasms
Sleep Disorders

Signs and Symptoms
Neoplasms
Neoplasms by Site
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009