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

NCT00569166 | Completed Results

• 4 other identifiers: CDR0000579010P30CA015083MC06C806-005157
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Fatigue; Hot Flashes; Sleep Disorders

Keywords

fatigue; sleep disorders; ductal breast carcinoma in situ; lobular breast carcinoma in situ; breast cancer; hot flashes

Outcome Measures

Primary Outcomes (1)

• The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (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.

  Week 1 and Week 9

Secondary Outcomes (8)

• Change From Baseline to Week 9 for PSQI Global Score

  Baseline and Week 9

• Change From Baseline to Week 9 on Blood Pressure Measurement

  Baseline and Week 9

• Change From Baseline to Week 9 for POMS Total Score and Subscales

  Baseline and 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

  Baseline and Week 9

• Change From Baseline to Week 9 for BFI Fatigue Scores

  Baseline and Week 9

Study Arms (3)

Paced breathing (15 min once daily, 6 breaths/min)

ACTIVE COMPARATOR

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)

Paced breathing (15 min twice daily, 6 breaths/min)

ACTIVE COMPARATOR

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)

Paced breathing (10 min once daily, 14 breaths/min)

PLACEBO COMPARATOR

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)

Interventions

Paced breathing (15 min once daily, 6 breaths/min) BEHAVIORAL

Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Paced breathing (15 min once daily, 6 breaths/min)

Paced breathing (15 min twice daily, 6 breaths/min) BEHAVIORAL

Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Paced breathing (15 min twice daily, 6 breaths/min)

Paced breathing (10 min once daily, 14 breaths/min) BEHAVIORAL

Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.

Paced breathing (10 min once daily, 14 breaths/min)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Hot Flashes; Sleep Wake Disorders; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Dr. Amit Sood
• Organization: Mayo Clinic

sood.amit@mayo.edu

507-538-7623

Study Officials

• Amit Sood, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 14, 2012
• Last Updated: August 7, 2017
• Results First Posted: December 6, 2011

Record last verified: 2011-11

Locations

US (1)