Energy Balance and Breast Cancer Aspects-II

Stage II Breast Cancer Clinical Trial

— EBBA-II  

Official title:

Energy Balance and Breast Cancer Aspects-II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02240836
• Other study ID #: 2014/945-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 31, 2027

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Lobular
• DCIS Grade 3
• Stage I Breast Cancer
• Stage II Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo
Norway	St. Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	St. Olavs Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (9)

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

Edvardsen E, Hem E, Anderssen SA. End criteria for reaching maximal oxygen uptake must be strict and adjusted to sex and age: a cross-sectional study. PLoS One. 2014 Jan 14;9(1):e85276. doi: 10.1371/journal.pone.0085276. eCollection 2014. — View Citation

Friedenreich CM, Woolcott CG, McTiernan A, Ballard-Barbash R, Brant RF, Stanczyk FZ, Terry T, Boyd NF, Yaffe MJ, Irwin ML, Jones CA, Yasui Y, Campbell KL, McNeely ML, Karvinen KH, Wang Q, Courneya KS. Alberta physical activity and breast cancer prevention trial: sex hormone changes in a year-long exercise intervention among postmenopausal women. J Clin Oncol. 2010 Mar 20;28(9):1458-66. doi: 10.1200/JCO.2009.24.9557. Epub 2010 Feb 16. — View Citation

Furberg AS, Veierod MB, Wilsgaard T, Bernstein L, Thune I. Serum high-density lipoprotein cholesterol, metabolic profile, and breast cancer risk. J Natl Cancer Inst. 2004 Aug 4;96(15):1152-60. doi: 10.1093/jnci/djh216. — View Citation

Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available. — View Citation

Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. doi: 10.1001/jama.289.3.323. — View Citation

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

Thune I, Njolstad I, Lochen ML, Forde OH. Physical activity improves the metabolic risk profiles in men and women: the Tromso Study. Arch Intern Med. 1998 Aug 10-24;158(15):1633-40. doi: 10.1001/archinte.158.15.1633. Erratum In: Arch Intern Med 1998 Jan 11;159(1):17. — View Citation

Outcome

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