Energy Balance and Breast Cancer Aspects-II (EBBA-II)

University of Oslo (UIO)

Status: Active, not recruiting

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

Treatments: Other: Intervention. Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02240836

2014/945-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 545 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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545 participants in 2 patient groups

Intervention. Exercise

Experimental group

Description:

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

Treatment:

Other: Intervention. Exercise

Control group

No Intervention group

Description:

Control group, standard treatment regimen