Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Control group, standard treatment regimen

Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.

Intervention. Exercise

Inger Thune, MD. PhD

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.

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.

Energy Balance and Breast Cancer Aspects-II

Energy Balance and Breast Cancer Aspects-II Study

Ratio between the amount of CO2 produced in metabolism and O2 used

Blood lactate from fingertip one minute after test

Time from baseline to the date of cancer symptoms or death

Time from baseline until the date of death, regardless of the cause of death

Time from baseline until the date of breast cancer-specific death

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

Change in VO2max from baseline to 12 months

Change in systolic blood pressure from baseline to 12 months

Change in diastolic blood pressure from baseline to 12 months

Change in total cholesterol from baseline to 12 months

Change in LDL cholesterol from baseline to 12 months

Change in HDL cholesterol from baseline to 12 months

Change in total cholesterol/HDL cholesterol from baseline to 12 months

Change in concentrations of HbA1c from baseline to 12 months

Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months

Change in concentrations of triglycerides from baseline to 12 months

Change in concentrations of CRP (mg/L) from baseline to 12 months

Change in heart rate from baseline to 12 months

Change in total fat from baseline to 12 months

Change in truncated fat from baseline to 12 months

Change in waist circumference from baseline to 12 months

Change in energy from food diary from baseline to 12 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Energy Balance and Breast Cancer Aspects-II	NCT02240836	DCIS Grade 3 Stage I Breast ... Stage II Breast... LCIS, Lobular C...	Intervention. E...	18 Years - 75 Years	Oslo University Hospital
Energy Balance and Breast Cancer Aspects-II	NCT02240836	DCIS Grade 3 Stage I Breast ... Stage II Breast... LCIS, Lobular C...	Intervention. E...	18 Years - 75 Years	Oslo University Hospital

Spots Global Cancer Trial Database for lcis, lobular carcinoma in situ