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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT02159157
Eligibility Criteria:
Inclusion Criteria:
1. Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
2. Patients must have recovered from prior surgery.
3. Patients must be able to walk unassisted without oxygen
4. Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
5. Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
6. Karnofsky performance status \> or = to 80%.
7. Previous or ongoing Physical therapy treatments are acceptable.
8. Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
9. Participants must have a baseline activity level of \< 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).
Exclusion Criteria:
1. Patients less than 18 years of age.
2. Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
3. Patients who are oxygen dependent.
4. Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
5. Patients with a Karnofsky performance status of \< 80%.
6. Pregnant.
7. Unable to read or write in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02159157
Study Brief:
Protocol Section:
NCT02159157