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NCT Number: NCT02240836

Energy Balance and Breast Cancer Aspects-II

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.

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Key information

Conditions

DCIS Grade 3 Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ LCIS, Lobular Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage I Breast Cancer Stage II Breast Cancer

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention. Exercise

Other

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

Other names: Physical activity

Primary outcomes

  1. VO2max

    Time frame: Baseline,12 months

    Change in VO2max from baseline to 12 months

Secondary outcomes

  1. BMI

    Time frame: Baseline,12 months

    Change in BMI from baseline to 12 months

  2. Systolic blood pressure

    Time frame: Baseline,12 months

    Change in systolic blood pressure from baseline to 12 months

  3. Diastolic blood pressure

    Time frame: Baseline,12 months

    Change in diastolic blood pressure from baseline to 12 months

  4. Total cholesterol

    Time frame: Baseline,12 months

    Change in total cholesterol from baseline to 12 months

  5. LDL cholesterol

    Time frame: Baseline,12 months

    Change in LDL cholesterol from baseline to 12 months

  6. HDL cholesterol

    Time frame: Baseline,12 months

    Change in HDL cholesterol from baseline to 12 months

  7. Total cholesterol/HDL cholesterol

    Time frame: Baseline,12 months

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

  8. HbA1c

    Time frame: Baseline,12 months

    Change in concentrations of HbA1c from baseline to 12 months

  9. Insulin

    Time frame: Baseline,12 months

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

  10. Triglycerides

    Time frame: Baseline,12 months

    Change in concentrations of triglycerides from baseline to 12 months

  11. C-reactive Protein (CRP)

    Time frame: Baseline,12 months

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

  12. Heart rate

    Time frame: Baseline,12 months

    Change in heart rate from baseline to 12 months

  13. Total fat

    Time frame: Baseline,12 months

    Change in total fat from baseline to 12 months

  14. Truncated fat

    Time frame: Baseline,12 months

    Change in truncated fat from baseline to 12 months

  15. Waist circumference

    Time frame: Baseline,12 months

    Change in waist circumference from baseline to 12 months

  16. Energy from food diary

    Time frame: Baseline,12 months

    Change in energy from food diary from baseline to 12 months

  17. Metabolic syndrome

    Time frame: 12 months

    Dichotomous outcome (yes/no)

Other outcomes

  1. Respiratory Quotient (RQ)

    Time frame: 12 months

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

  2. Lactate

    Time frame: 12 months

    Blood lactate from fingertip one minute after test

  3. HRmax

    Time frame: 12 months

    Maximal heart rate

  4. BORGmax

    Time frame: 12 months

    Subjective measure of exhaustion

  5. Disease-free survival

    Time frame: Baseline, 1 year, 2 years, 5 years, 10 years

    Time from baseline to the date of cancer symptoms or death

  6. Overall mortality

    Time frame: Baseline, 1 year, 2 years, 5 years, 10 years

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

  7. Breast cancer-specific mortality

    Time frame: Baseline, 1 year, 2 years, 5 years, 10 years

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

  8. Other exploratory

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • St. Olavs Hospital
  • The Research Council of Norway

Registry information

Official study title

Energy Balance and Breast Cancer Aspects-II Study

Acronym: EBBA-II

Important dates

Study start
2014
Primary completion
2017
Study completion
2027
First posted
Sep 16, 2014
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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