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Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

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) 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
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 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.

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 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.

Outcome Description:

To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention

Outcome Time Frame:

Baseline, 6 months

Safety Issue:


Principal Investigator

Mary Chamberlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756