Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT00569166
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00569166
Study Brief:
Protocol Section:
NCT00569166