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The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study

Given that this is the first study to explore the potential effects of exercise training on
exercise capacity, tumor vascularity and response in women undergoing neoadjuvant
chemotherapy for operable breast cancer, prior to the initiation of the full investigation,
we will conduct a small vanguard study to ensure we can achieve acceptable exercise
adherence rates in the absence of dose-limiting toxicities (DLTs). Specifically, three
operable breast cancer patients will be recruited and enrolled as described below and
perform exercise training for a minimum of six weeks. If acceptable exercise rates are
observed in the absence of severe DLTs during this time, we will proceed with the full
investigation (recruitment of additional 20 patients) (see Figure 2). Using a prospective,
randomized design, potential participants will be identified and screened for eligibility by
an assigned Breast Protocol Nurse (TBD) via medical record review of patients scheduled for
their primary neoadjuvant chemotherapy consultation at DCCC

Inclusion Criteria:

- Histologically confirmed operable primary breast cancer

- Age 18 or older

- Karnofsky performance status greater than 70

- No previous malignancy

- Absence of significant cardiac disease (left ventricular ejection fraction greater
than or equal to 50%)

- No hormonal replacement therapy use within the past month

- Not pregnant

- Ability to read and understand English

- Signed written informed consent prior to beginning protocol specific procedures

- Willing to travel to DUMC to exercise three times per week

- Primary treating oncologist approval

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Lee W Jones, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:

Pro00007112 (8426)



Start Date:

September 2006

Completion Date:

September 2010

Related Keywords:

  • Breast Cancer
  • Exercise Intervention
  • Breast Cancer
  • Neo-Adjuvant Therapy
  • Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy
  • Breast Neoplasms



Duke University Medical CenterDurham, North Carolina  27710