Energy Balance and Breast Cancer Aspects-II

Study Overview
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Brief Summary
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The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims are to determine whether the 12 month exercise program will influence factors associated with metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be assessed and evaluated.

Detailed Description
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The EBBA (Energy Balance and Breast cancer Aspects)-II study is a randomized clinical 12 month physical activity intervention trial, including female breast cancer patients diagnosed with histologically verified invasive cancer stage I-II or carcinoma in situ (DCIS/LCIS) grade 3. Participants are randomized to either control or intervention group 10 days +/- 2 days after surgery. The intervention start 3 weeks after surgery and continue throughout adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). The intervention group receive a detailed training program based on their own ventilatory maximal oxygen consumption (VO2max) at baseline. They meet for supervised training sessions in groups for 60 minutes x 2/ week during 12 months. In addition, they are informed to exercise at home for at least of total 120 minutes weekly aiming to perform a total of 240 minutes exercise, weekly. The patients in the control group receive standard of care without any restrictions regarding exercise. All participants will undergo a series of measurements before surgery, after surgery, 6 months and after the 12 months exercise intervention trial. Clinical measurements will include anthropometric measurements, fasting blood, fecal and urine samples and cardiopulmonary exercise test (CPET). Complete questionnaires (food diary (PFD)/food frequency questionnaires (FFQ), quality of life (QoL)). All participants will come to clinical examination and fasting blood sampling after 2, 3, 5 and 10 years follow up.

Official Title
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Energy Balance and Breast Cancer Aspects-II Study

Conditions
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DCIS Grade 3, Stage I Breast Cancer, Stage II Breast Cancer, LCIS, Lobular Carcinoma in Situ

Intervention / Treatment
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* Other: Intervention. Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Newly diagnosed DCIS grade 3 or invasive breast cancer stage I, II, histologically verified. All ethnic groups, but participants have to speak and write the Norwegian language. Ability to join and maintain an intervention for 12 months Exclusion Criteria: Verified heart disease Dysregulated diabetes mellitus or thyroid disorders Muscular and skeletal or other disorders excluding regular physical activity performance Body Mass Index >40 kg/m2 Previous surgical treatment for obesity Travel distance >1.5 hour from home to study site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention. Exercise<br>The intervention starts 3-4 weeks after surgical treatment. The exercise program is performed in parallel with standard breast cancer treatment, and take place in supervised exercise groups by experienced physiotherapists. The duration of the intervention exercise program is 12 months, and the participants will attend the exercise groups for training 60 minutes twice a week. Additionally, they will exercise at home for at least 120 minutes a week, aiming to perform a total of 240 minutes of exercise per week | Other: Intervention. Exercise<br>* Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.<br>* Other names: Physical activity;|
| No Intervention: Control group<br>Control group, standard treatment regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max | Change in VO2max from baseline to 12 months | Baseline,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Change in BMI from baseline to 12 months | Baseline,12 months | 
| Systolic blood pressure | Change in systolic blood pressure from baseline to 12 months | Baseline,12 months | 
| Diastolic blood pressure | Change in diastolic blood pressure from baseline to 12 months | Baseline,12 months | 
| Total cholesterol | Change in total cholesterol from baseline to 12 months | Baseline,12 months | 
| LDL cholesterol | Change in LDL cholesterol from baseline to 12 months | Baseline,12 months | 
| HDL cholesterol | Change in HDL cholesterol from baseline to 12 months | Baseline,12 months | 
| Total cholesterol/HDL cholesterol | Change in total cholesterol/HDL cholesterol from baseline to 12 months | Baseline,12 months | 
| HbA1c | Change in concentrations of HbA1c from baseline to 12 months | Baseline,12 months | 
| Insulin | Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months | Baseline,12 months | 
| Triglycerides | Change in concentrations of triglycerides from baseline to 12 months | Baseline,12 months | 
| C-reactive Protein (CRP) | Change in concentrations of CRP (mg/L) from baseline to 12 months | Baseline,12 months | 
| Heart rate | Change in heart rate from baseline to 12 months | Baseline,12 months | 
| Total fat | Change in total fat from baseline to 12 months | Baseline,12 months | 
| Truncated fat | Change in truncated fat from baseline to 12 months | Baseline,12 months | 
| Waist circumference | Change in waist circumference from baseline to 12 months | Baseline,12 months | 
| Energy from food diary | Change in energy from food diary from baseline to 12 months | Baseline,12 months | 
| Metabolic syndrome | Dichotomous outcome (yes/no) | 12 months |