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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT04876560
Eligibility Criteria:
Inclusion criteria:
* Adult women (≥ 37 years of age);
* histological evidence of primary invasive breast cancer at stages I-IIIA;
* treatment: mastectomy followed by antiestrogen therapy;
* the ability to ambulate independently, that corresponded to scoring 0 or 1 of the Eastern Cooperative Oncology Performance Status
Exclusion criteria:
* Any other malignancy ≤ 5 years;
* co-existing medical conditions (e.g., obstructive ileus) that would interfere with the study protocol;
* malabsorption; serious chronic diseases (e.g. advanced heart, liver or renal failure, congenital metabolic diseases);
* active infection;
* severe psychiatric illness;
* alcoholism or drug use;
* vitamin or inorganic supplement use ≤ 6 months prior to screening;
* vegan or macrobiotic diet ≤ 5 years prior to screening;
* using weight loss medications.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
37 Years
Maximum Age:
68 Years
Study:
NCT04876560
Study Brief:
Protocol Section:
NCT04876560