Clinical trial NCT00405678: Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.
Official title: The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Exercise Intervention
Breast Cancer
Neo-Adjuvant Therapy
Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2006-11-30
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test
timeFrame: 3 months
Secondary outcomes:
measure: Adherence to fitness program
timeFrame: 3 months
measure: Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale.
timeFrame: 3 months
measure: Determine and define feasibility for an adequately powered Phase III study.
timeFrame: 3 months
measure: Determine effects of exercise training on tumor vascularity, systemic response and tumor response.
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lee W Jones, PhD
role: PRINCIPAL_INVESTIGATOR
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