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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01482702
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal (last period 12 mos prior to study enrollment or oophorectomy)
* Age 40-65
* DCIS, Stage I, II, III Breast Cancer
* BMI between 27-50
* Completed chemotherapy to treat early stage breast cancer (Stage I-III) no less then 6 months and no more than 48 months from start of study or for specific aim 3 Diagnosis of DCIS or Stage I breast cancer who did not receive chemotherapy.
Exclusion Criteria:
* Participant can not have a psychotic or central nervous system impairment that would limit compliance with study requirements
* Evidence of metastatic disease
* Chemotherapy for cancer other than breast cancer
* Diabetes mellitus, uncontrolled hypo or hyper thyroidism, liver failure
* Celiac sprue, inflammatory bowel disease
* Inability to walk for exercise
* Lymphedema as indicated by a 2 cm circumference difference at the elbow
* weight loss in the previous 6 months of 10 lbs or greater
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01482702
Study Brief:
Protocol Section:
NCT01482702