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:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 12:23 AM
NCT ID:
NCT00068458
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage I, II, or IIIA
* Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal Status
* Premenopausal, defined as at least 1 of the following:
* Less than 4 months since last menstrual period at diagnosis
* Follicle-stimulating hormone level in the premenopausal range
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* No calcium-based kidney stones
Cardiovascular
* No angina within the past 6 months
* No myocardial infarction within the past 6 months
* No abnormal MUGA and/or stress test
Other
* Not pregnant or nursing
* Access to a telephone
* Able to read and speak English
* No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No history of hyperthyroidism or hypothyroidism
* No paralysis
* No osteoarthritis with uncontrolled joint pain that would preclude exercise
* No diverticulitis
* No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires
* No medical condition that would interfere with body composition assessment
* No medical condition for which unsupervised exercise is contraindicated
* No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* No prior bilateral oophorectomy
* No prior amputation
* No concurrent transverse rectus abdominis myocutaneous surgery
* No concurrent surgery
Other
* No concurrent blood-thinners (e.g., coumadin or warfarin)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00068458
Study Brief:
Protocol Section:
NCT00068458