Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

Study Overview
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Brief Summary
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The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.

Detailed Description
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Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.

Official Title
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Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

Conditions
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Early Stage Breast Cancer (Stage 0-III)

Intervention / Treatment
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* Other: Exercise Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to participate in study Women aged 18 and older Stage 0 to III breast cancer prior to any treatment and at time of diagnosis Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy Adequate fitness to participate in a physical activity as assessed by the investigator Willing and able to participate in a prescribed exercise program Exclusion Criteria: Metastatic breast cancer (Stage IV) Initiation of treatment regimen prior to enrollment Treatment for breast cancer not requiring chemotherapy or radiation therapy Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential). Currently lactating Do not read, understand, or speak English Eligible participants will not be included if they have: known cardiac disease, uncontrolled hypertension, uncontrolled thyroid disease, diabetes mellitus, mental illness, infection, immune or endocrine abnormality, body weight reduction I10% in past 6 months, and positive exercise stress test. Major surgery within last 6 months that requires exercise restriction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. | Other: Exercise Regimen<br>* Exercise instruction<br>|
| No Intervention: Control Group<br>The control group will receive basic information on physical activity but not be instructed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CRP | The primary endpoint for this study change in C-reactive protein. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory values | Compare changes in: Glucose Insulin Estradiol Testosterone |  | 
| Change in body composition | Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups. |  | 
| Quality of Life | Quality of Life will be measured and compared between the groups |  | 
| Overall Survival | Comparing overall survival and progression free survival between groups. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Exercise, CRP, C-reactive protein, BMI, Nevada Cancer Institute, Rehabilitation, Prescriptive exercise, Physical Activity, DEXA, Obesity, lifestyle intervention, Early Stage Breast Cancer Patients (stage 0-III)