A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer

Study Overview
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Brief Summary
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This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.

Detailed Description
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This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.

Official Title
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A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer

Conditions
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Early Stage Breast Cancer

Intervention / Treatment
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* Behavioral: Exercise prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks. Patients must have recovered from prior surgery. Patients must be able to walk unassisted without oxygen Patients must complete the Physical Activity Readiness questionnaire with No answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study. Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement. Karnofsky performance status > or = to 80%. Previous or ongoing Physical therapy treatments are acceptable. Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials. Participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening). Exclusion Criteria: Patients less than 18 years of age. Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months. Patients who are oxygen dependent. Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study. Patients with a Karnofsky performance status of < 80%. Pregnant. Unable to read or write in English.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| No Intervention: Arm A<br>Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy. Phone calls designed to support the patient to maintain current activity level. | |
| Placebo Comparator: Arm B<br>Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy. Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week. Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription. | Behavioral: Exercise prescription<br>* A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity as measured by the Activity Log | A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis. | from baseline to week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Received Dose Intensity of chemotherapy (RDI) | The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment) | 32 weeks | 
| Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F | Fatigue as measured by the FACIT-F survey | baseline (Day -28 to 1), week 24, 32 weeks | 
| Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin |  | baseline (Day -28 to 1), 32 weeks | 
| Change from Baseline (day -28 to day 1) C-reactive protein | levels of C- reactive protein | Baseline (day -28 to day 1) and week 32 | 
| Change from Baseline (Day -28 to day 1) Fasting insulin | Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32 | Baseline (day -28 to day 1) and week 32 | 
| Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day) |  | baseline (day -28 to day 1) and week 32 | 
| Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score |  | baseline (day -28 to day 1) and week 32 | 
| Change in Resting heart rate from baseline (day -28 to day 1) |  | baseline (day -28 to day 1) and week 32 | 
| Change in Waist-hip ratio from baseline (day -28 to day 1) |  | baseline (day -28 to day 1) and week 32 | 
| Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data | Average steps per week for weeks 1-32 | weekly for 32 weeks | 
| Measures how likely a person is to continue with exercise prescription. | How the participant is feeling about the exercise. | From baseline to Week 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, exercise