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Paced Breathing for Hot Flashes: A Randomized Phase II Study


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Fatigue, Hot Flashes, Sleep Disorders

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Trial Information

Paced Breathing for Hot Flashes: A Randomized Phase II Study


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 compact disc (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.

Inclusion 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:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9

Outcome Description:

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.

Outcome Time Frame:

Week 1 and Week 9

Safety Issue:

No

Principal Investigator

Amit Sood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000579010

NCT ID:

NCT00569166

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Hot Flashes
  • Sleep Disorders
  • fatigue
  • sleep disorders
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • breast cancer
  • hot flashes
  • Breast Neoplasms
  • Fatigue
  • Sleep Disorders
  • Parasomnias
  • Hot Flashes

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905