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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT02081612
Eligibility Criteria:
Inclusion Criteria:
* Woman with a diagnosis of breast cancer, stage I, II, or III
* Age ≥ 18
* ECOG performance status ≤ 1
* Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
* BMI ≥ 30
* Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
* Signed informed consent
* Any receptor status
* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
Exclusion Criteria:
* Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
* Diagnosis of metastatic breast cancer
* Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
* Current use of commercial or natural/herbal weight loss supplements
* Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
* Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Personal history of an eating disorder
* Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02081612
Study Brief:
Protocol Section:
NCT02081612