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

Energy Balance and Breast Cancer Aspects-II Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage I Breast Cancer; Stage II Breast Cancer; DCIS Grade 3; LCIS, Lobular Carcinoma in Situ
• Intervention / Treatment: Other: Intervention. Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 545
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital
  • Trondheim, Norway, 7000
    • St. Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Physical activity
No Intervention: Control group; Control group, standard treatment regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max	Change in VO2max from baseline to 12 months	Baseline,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Change in BMI from baseline to 12 months	Baseline,12 months
Systolic blood pressure	Change in systolic blood pressure from baseline to 12 months	Baseline,12 months
Diastolic blood pressure	Change in diastolic blood pressure from baseline to 12 months	Baseline,12 months
Total cholesterol	Change in total cholesterol from baseline to 12 months	Baseline,12 months
LDL cholesterol	Change in LDL cholesterol from baseline to 12 months	Baseline,12 months
HDL cholesterol	Change in HDL cholesterol from baseline to 12 months	Baseline,12 months
Total cholesterol/HDL cholesterol	Change in total cholesterol/HDL cholesterol from baseline to 12 months	Baseline,12 months
HbA1c	Change in concentrations of HbA1c from baseline to 12 months	Baseline,12 months
Insulin	Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months	Baseline,12 months
Triglycerides	Change in concentrations of triglycerides from baseline to 12 months	Baseline,12 months
C-reactive Protein (CRP)	Change in concentrations of CRP (mg/L) from baseline to 12 months	Baseline,12 months
Heart rate	Change in heart rate from baseline to 12 months	Baseline,12 months
Total fat	Change in total fat from baseline to 12 months	Baseline,12 months
Truncated fat	Change in truncated fat from baseline to 12 months	Baseline,12 months
Waist circumference	Change in waist circumference from baseline to 12 months	Baseline,12 months
Energy from food diary	Change in energy from food diary from baseline to 12 months	Baseline,12 months
Metabolic syndrome	Dichotomous outcome (yes/no)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Quotient (RQ)	Ratio between the amount of CO2 produced in metabolism and O2 used	12 months
Lactate	Blood lactate from fingertip one minute after test	12 months
HRmax	Maximal heart rate	12 months
BORGmax	Subjective measure of exhaustion	12 months
Disease-free survival	Time from baseline to the date of cancer symptoms or death	Baseline, 1 year, 2 years, 5 years, 10 years
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
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 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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Research Council of Norway; St. Olavs Hospital
• Investigators: Principal Investigator: Inger Thune, MD. PhD, The Department of Oncology, Ullevål, Oslo University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 31, 2017
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimated): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Lobular
• Other Study ID Numbers: 2014/945-1