Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.

Study Overview
=================
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

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise Training
* Behavioral: Chemo only


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects receiving chemo and exercise training | Behavioral: Exercise Training<br>* Subjects receiving chemo with exercise training<br>|
| Experimental: 2<br>Subjects receiving chemo only | Behavioral: Exercise Training<br>* Subjects receiving chemo with exercise training<br>Behavioral: Chemo only<br>* Subjects receiving chemo only<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to fitness program |  | 3 months | 
| Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale. |  | 3 months | 
| Determine and define feasibility for an adequately powered Phase III study. |  | 3 months | 
| Determine effects of exercise training on tumor vascularity, systemic response and tumor response. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise Intervention, Breast Cancer, Neo-Adjuvant Therapy, Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy