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

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ClinicalTrials.gov Identifier: NCT02240836
Recruitment Status : Active, not recruiting
First Posted : September 16, 2014
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
St. Olavs Hospital
The Research Council of Norway
Information provided by (Responsible Party):
Inger Thune, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
DCIS Grade 3 Stage I Breast Cancer Stage II Breast Cancer LCIS, Lobular Carcinoma in Situ Other: Intervention. Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Energy Balance and Breast Cancer Aspects-II Study
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 31, 2017
Estimated Study Completion Date : October 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. VO2max [ Time Frame: Baseline,12 months ]
    Change in VO2max from baseline to 12 months


Secondary Outcome Measures :
  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 Outcome Measures:
  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




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
Oslo University Hospital
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway, 7000
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
The Research Council of Norway
Investigators
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Principal Investigator: Inger Thune, MD. PhD The Department of Oncology, Ullevål, Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Inger Thune, Oslo University Hospital:
Statistical Analysis Plan  [PDF] April 20, 2021

Publications:

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Responsible Party: Inger Thune, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02240836    
Other Study ID Numbers: 2014/945-1
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Carcinoma, Lobular
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary