DCIS Grade 3, LCIS, Lobular Carcinoma in Situ, Stage I Breast Cancer, Stage II Breast Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERIntervention. Exercise
Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.
Sponsors
St. Olavs Hospital
The Research Council of Norway
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2max | Baseline,12 months | Change in VO2max from baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterol | Baseline,12 months | Change in LDL cholesterol from baseline to 12 months |
| HDL cholesterol | Baseline,12 months | Change in HDL cholesterol from baseline to 12 months |
| HbA1c | Baseline,12 months | Change in concentrations of HbA1c from baseline to 12 months |
| BMI | Baseline,12 months | Change in BMI from baseline to 12 months |
| Triglycerides | Baseline,12 months | Change in concentrations of triglycerides from baseline to 12 months |
| C-reactive Protein (CRP) | Baseline,12 months | Change in concentrations of CRP (mg/L) from baseline to 12 months |
| Heart rate | Baseline,12 months | Change in heart rate from baseline to 12 months |
| Total fat | Baseline,12 months | Change in total fat from baseline to 12 months |
| Truncated fat | Baseline,12 months | Change in truncated fat from baseline to 12 months |
| Waist circumference | Baseline,12 months | Change in waist circumference from baseline to 12 months |
| Energy from food diary | Baseline,12 months | Change in energy from food diary from baseline to 12 months |
| Metabolic syndrome | 12 months | Dichotomous outcome (yes/no) |
| Total cholesterol/HDL cholesterol | Baseline,12 months | Change in total cholesterol/HDL cholesterol from baseline to 12 months |
| Total cholesterol | Baseline,12 months | Change in total cholesterol from baseline to 12 months |
| Systolic blood pressure | Baseline,12 months | Change in systolic blood pressure from baseline to 12 months |
| Diastolic blood pressure | Baseline,12 months | Change in diastolic blood pressure from baseline to 12 months |
| Insulin | Baseline,12 months | Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lactate | 12 months | Blood lactate from fingertip one minute after test |
| HRmax | 12 months | Maximal heart rate |
| BORGmax | 12 months | Subjective measure of exhaustion |
| Disease-free survival | Baseline, 1 year, 2 years, 5 years, 10 years | Time from baseline to the date of cancer symptoms or death |
| Overall mortality | Baseline, 1 year, 2 years, 5 years, 10 years | Time from baseline until the date of death, regardless of the cause of death |
| Breast cancer-specific mortality | Baseline, 1 year, 2 years, 5 years, 10 years | Time from baseline until the date of breast cancer-specific death |
| Other exploratory | 12 months | Forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), diffusing capacity of the lung for carbon monoxide (DLco) Inflammatory markers, prothrombotic markers, urinary markers, adipokines Levels of sex steroid hormones Growth factors (Insulin-like growth factor \[IGF\], insulin, insulin-like growth factor binding protein \[IGFBP\]) Microenvironment of the breast, tumor infiltrating lymphocytes (TILS), Crown like structures (CLS) Microbiota Quality of life and dietary factors |
| Respiratory Quotient (RQ) | 12 months | Ratio between the amount of CO2 produced in metabolism and O2 used |
Countries
Norway
Outcome results
None listed