Energy Balance and Breast Cancer Aspects-II (EBBA-II)
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|ClinicalTrials.gov Identifier: NCT02240836|
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|DCIS Grade 3 Stage I Breast Cancer Stage II Breast Cancer||Other: Intervention. Exercise||Not Applicable|
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 with ductal carcinoma in situ (DCIS) 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 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 month. 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 control group are told to follow standard care regime.
- All participants will undergo a series of measurement before surgery, after surgery, 6 month and after the 12 month exercise intervention trial. Clinical measurements will include anthropometric measurements, fasting blood, saliva, fecal and urine samples and cardiopulmonary exercise test (CPET). They will also use heart rate monitors and accelerometers and complete questionnaires (food diary/food frequency questionnaires (FFQ), quality of life).
- All participants will come to clinical examination and fasting blood sampling after 2, 3, 4, 5 and 10 years follow up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Energy Balance and Breast Cancer Aspects-II Study|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||June 2026|
Experimental: Intervention. Exercise
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
Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.
Other Name: Physical activity
No Intervention: Control group
Control group, standard treatment regimen
- Metabolic profile [ Time Frame: Baseline, 6 month, 12 months, 10 years ]Lipids, Lipoproteins, glucose, blood pressure, body composition, insulin, inflammatory markers, prothrombic markers, urinary markers, adipokines
- Survival [ Time Frame: 10 years ]Relapse of breast cancer disease, Breast Cancer Specific Mortality, Overall mortality, Disease-free survival, Recurrence-free interval
- Dietary intake [ Time Frame: Baseline, 12 months, 2 years ]FFQ, Food diary Energy, nutrients and food
- Quality of Life [ Time Frame: Baseline, 12 months, 2 years ]QoL, fatigue, anxiety, depression
- Microenvironment [ Time Frame: Baseline ]Tumor infiltrating lymphocytes (TILS), tumor associated macrophages (TAMS), adipocytes, angiogenetic factors, Crown like Structures
- Hormones [ Time Frame: Baseline, 6 month, 12 months, 10 years ]Sex steroid hormones
- Cardiopulmonary function [ Time Frame: Baseline, 6 months, 12 months, 2 years ]CPET, VO2max, forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), diffusing capacity of the lung for carbon monoxide (DLco)
- Growth factors [ Time Frame: Baseline, 6 month, 12 month, 10 years ]Insulin-like growth factor (IGF), insulin, growth hormones, Insulin-like growth factor binding protein (IGFBP)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240836
|Contact: Inger Thune, MD. PhDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Contact: Inger Thune, MD. PhD +4791372717 email@example.com|
|Principal Investigator: Inger Thune, MD. PhD|
|Sub-Investigator: Erik A Wist, MD, PhD|
|Sub-Investigator: Ellen Schlichting, MD, PhD|
|St. Olavs Hospital||Recruiting|
|Trondheim, Norway, 7000|
|Contact: Gro Bertheussen, MD. PhD +4791545550 firstname.lastname@example.org|
|Sub-Investigator: Gro Bertheussen, MD. PhD|
|Sub-Investigator: Hans Fjosne, MD PhD|
|Principal Investigator:||Inger Thune, MD. PhD||The Cancer Center, Oslo University Hospital|