Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway
- 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) new
or progressive metastatic carcinoma of the breast greater than 4 weeks from last
treatment for metastatic disease and greater than 12 months from completing adjuvant
therapy, including trastuzumab.
- Physically able to undertake a moderate physical activity program.
- Greater than 4 weeks from any radiation treatments for metastatic disease.
- Able to follow directions and fill out questionnaires and physical activity diaries
- 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 care 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)
- Karnofsky performance status ≥ 80%
- Life expectancy of 6 months or more.
- Previous Physical Therapy consultation and treatments acceptable.
- 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 leptomeningeal or any central nervous system (CNS) disease, treated or
- 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.