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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
Sponsor:
Collaborators:
St. Olavs Hospital
The Research Council of Norway
Information provided by (Responsible Party):
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 factors associated metabolic profile, tumor growth and cardiopulmonary function. Secondary aims are to determine whether the 12 month exercise program will influence 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 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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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. 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


Secondary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]
    Relapse of breast cancer disease, Breast Cancer Specific Mortality, Overall mortality, Disease-free survival, Recurrence-free interval

  2. Dietary intake [ Time Frame: Baseline, 12 months, 2 years ]
    FFQ, Food diary Energy, nutrients and food

  3. Quality of Life [ Time Frame: Baseline, 12 months, 2 years ]
    QoL, fatigue, anxiety, depression

  4. Microenvironment [ Time Frame: Baseline ]
    Tumor infiltrating lymphocytes (TILS), tumor associated macrophages (TAMS), adipocytes, angiogenetic factors, Crown like Structures

  5. Hormones [ Time Frame: Baseline, 6 month, 12 months, 10 years ]
    Sex steroid hormones

  6. 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)

  7. 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)



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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


Contacts
Contact: Inger Thune, MD. PhD 004791372717 inger.thune@uit.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Inger Thune, MD. PhD    +4791372717    inger.thune@uit.no   
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    gro.f.bertheussen@ntnu.no   
Sub-Investigator: Gro Bertheussen, MD. PhD         
Sub-Investigator: Hans Fjosne, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
The Research Council of Norway
Investigators
Principal Investigator: Inger Thune, MD. PhD The Cancer Center, Oslo University Hospital

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02240836     History of Changes
Other Study ID Numbers: 2014/945-1
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases