Stage II Breast Cancer Clinical Trial
— EBBA-IIOfficial title:
Energy Balance and Breast Cancer Aspects-II Study
Verified date | April 2024 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 545 |
Est. completion date | October 31, 2027 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo | |
Norway | St. Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | St. Olavs Hospital, The Research Council of Norway |
Norway,
Courneya KS, McKenzie DC, Mackey JR, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Vallerand JR, Adams SC, Proulx C, Dolan LB, Wooding E, Segal RJ. Subgroup effects in a randomised trial of different types and doses of exercise during breast cancer chemotherapy. Br J Cancer. 2014 Oct 28;111(9):1718-25. doi: 10.1038/bjc.2014.466. Epub 2014 Aug 21. — View Citation
Courneya KS, Segal RJ, McKenzie DC, Dong H, Gelmon K, Friedenreich CM, Yasui Y, Reid RD, Crawford JJ, Mackey JR. Effects of exercise during adjuvant chemotherapy on breast cancer outcomes. Med Sci Sports Exerc. 2014 Sep;46(9):1744-51. doi: 10.1249/MSS.0000000000000297. — View Citation
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Peel AB, Thomas SM, Dittus K, Jones LW, Lakoski SG. Cardiorespiratory fitness in breast cancer patients: a call for normative values. J Am Heart Assoc. 2014 Jan 13;3(1):e000432. doi: 10.1161/JAHA.113.000432. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Respiratory Quotient (RQ) | Ratio between the amount of CO2 produced in metabolism and O2 used | 12 months | |
Other | Lactate | Blood lactate from fingertip one minute after test | 12 months | |
Other | HRmax | Maximal heart rate | 12 months | |
Other | BORGmax | Subjective measure of exhaustion | 12 months | |
Other | Disease-free survival | Time from baseline to the date of cancer symptoms or death | Baseline, 1 year, 2 years, 5 years, 10 years | |
Other | Overall mortality | Time from baseline until the date of death, regardless of the cause of death | Baseline, 1 year, 2 years, 5 years, 10 years | |
Other | Breast cancer-specific mortality | Time from baseline until the date of breast cancer-specific death | Baseline, 1 year, 2 years, 5 years, 10 years | |
Other | Other exploratory | 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 |
12 months | |
Primary | VO2max | Change in VO2max from baseline to 12 months | Baseline,12 months | |
Secondary | BMI | Change in BMI from baseline to 12 months | Baseline,12 months | |
Secondary | Systolic blood pressure | Change in systolic blood pressure from baseline to 12 months | Baseline,12 months | |
Secondary | Diastolic blood pressure | Change in diastolic blood pressure from baseline to 12 months | Baseline,12 months | |
Secondary | Total cholesterol | Change in total cholesterol from baseline to 12 months | Baseline,12 months | |
Secondary | LDL cholesterol | Change in LDL cholesterol from baseline to 12 months | Baseline,12 months | |
Secondary | HDL cholesterol | Change in HDL cholesterol from baseline to 12 months | Baseline,12 months | |
Secondary | Total cholesterol/HDL cholesterol | Change in total cholesterol/HDL cholesterol from baseline to 12 months | Baseline,12 months | |
Secondary | HbA1c | Change in concentrations of HbA1c from baseline to 12 months | Baseline,12 months | |
Secondary | Insulin | Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months | Baseline,12 months | |
Secondary | Triglycerides | Change in concentrations of triglycerides from baseline to 12 months | Baseline,12 months | |
Secondary | C-reactive Protein (CRP) | Change in concentrations of CRP (mg/L) from baseline to 12 months | Baseline,12 months | |
Secondary | Heart rate | Change in heart rate from baseline to 12 months | Baseline,12 months | |
Secondary | Total fat | Change in total fat from baseline to 12 months | Baseline,12 months | |
Secondary | Truncated fat | Change in truncated fat from baseline to 12 months | Baseline,12 months | |
Secondary | Waist circumference | Change in waist circumference from baseline to 12 months | Baseline,12 months | |
Secondary | Energy from food diary | Change in energy from food diary from baseline to 12 months | Baseline,12 months | |
Secondary | Metabolic syndrome | Dichotomous outcome (yes/no) | 12 months |
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