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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT01983995
Eligibility Criteria:
Inclusion Criteria:
* Female, aged 50 years or older, postmenopausal.
* Patients with histologically proven stage 0-III invasive carcinoma of the breast that is estrogen receptor and/or progesterone receptor positive by immunohistochemical staining, who are planning to start treatment with a standard dose of aromatase inhibitor (AI) therapy.
* Subjects must have undergone surgical resection of their primary tumor, as indicated. The most recent surgery must have been performed at least 4 weeks before the baseline evaluation and no additional surgeries (including reconstructive procedures) should be planned during study participation.
* Cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before the baseline evaluation.
* Radiation therapy, if applicable, must have been completed at least 2 weeks before baseline evaluation.
* Eastern Cooperative Oncology Group performance status 0-2.
* Ability to operate the accelerometer
Exclusion Criteria:
* Diagnosis of sleep apnea or restless leg syndrome.
* Use of a wheelchair for ambulation most of the time.
* Second or third shift workers or other non-traditional sleep schedules.
* History of medical arthritic disease that could confound or interfere with evaluation of pain or activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), Parkinson's disease, and cancer involving the bone.
* Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01983995
Study Brief:
Protocol Section:
NCT01983995