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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01653366
Eligibility Criteria:
Inclusion Criteria:
* Subjects with measurable per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 and biopsy-able (as determined by Co-Investigator John Gemery, MD) metastatic carcinoma of the breast.
* Physically able to undertake a moderate physical activity program.
* Greater than 4 weeks from any radiation treatments for metastatic disease.
* standard of care biopsy must occur within 30 days of registration.
* Able to follow directions and fill out questionnaires and physical activity diaries in English.
* Willing to consent to biopsies and be randomly assigned to one of two study arms which may or may not include physical activity goal setting.
* Consents to be contacted via phone or internet (see Appendix K).
* No to all questions on Physical Activity Readiness Questionnaire (see appendix A) or approved by primary oncologist or other care provider provider for participation.
* Hb \>10 without transfusion, liver function tests less than 3 times upper limits of normal, normal thyroid-stimulating hormone (TSH), absolute neutrophil count (ANC) \>1500.
* Karnofsky performance status ≥ 80%
* Previous Physical Therapy consultation and treatments acceptable.
* Participation in other trials acceptable.
* CNS disease that is treated and stable by MRI for at least 6 months
Exclusion Criteria:
* Patients less than 18 years of age.
* Patients unable to give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
* Pregnant or nursing women.
* Patients with any untreated (CNS) disease.
* Patients with other active cancers requiring treatment.
* Patients with clotting or bleeding disorder precluding biopsy.
* Patients with significant cardiovascular disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.
* Current use of supplements containing conjugated linoleic acid, or use within the 30 days preceding registration.
* Persons with a known diagnosis of diabetes are not eligible. Prior use of metformin allowable if previously enrolled on MA.32 trial as part of their adjuvant therapy for early stage breast cancer.
* Persons of male gender.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01653366
Study Brief:
Protocol Section:
NCT01653366