Clinical trial NCT02240836: Energy Balance and Breast Cancer Aspects-II
Official title: Energy Balance and Breast Cancer Aspects-II Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: DCIS Grade 3
Stage I Breast Cancer
Stage II Breast Cancer
LCIS, Lobular Carcinoma in Situ
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: The Research Council of Norway
First posted: 2014-09-16
Enrollment: 545
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: VO2max
timeFrame: Baseline,12 months
Secondary outcomes:
measure: BMI
timeFrame: Baseline,12 months
measure: Systolic blood pressure
timeFrame: Baseline,12 months
measure: Diastolic blood pressure
timeFrame: Baseline,12 months
measure: Total cholesterol
timeFrame: Baseline,12 months
measure: LDL cholesterol
timeFrame: Baseline,12 months
measure: HDL cholesterol
timeFrame: Baseline,12 months
measure: Total cholesterol/HDL cholesterol
timeFrame: Baseline,12 months
measure: HbA1c
timeFrame: Baseline,12 months
measure: Insulin
timeFrame: Baseline,12 months
measure: Triglycerides
timeFrame: Baseline,12 months
measure: C-reactive Protein (CRP)
timeFrame: Baseline,12 months
measure: Heart rate
timeFrame: Baseline,12 months
measure: Total fat
timeFrame: Baseline,12 months
measure: Truncated fat
timeFrame: Baseline,12 months
measure: Waist circumference
timeFrame: Baseline,12 months
measure: Energy from food diary
timeFrame: Baseline,12 months
measure: Metabolic syndrome
timeFrame: 12 months
Other outcomes:
measure: Respiratory Quotient (RQ)
timeFrame: 12 months
measure: Lactate
timeFrame: 12 months
measure: HRmax
timeFrame: 12 months
measure: BORGmax
timeFrame: 12 months
measure: Disease-free survival
timeFrame: Baseline, 1 year, 2 years, 5 years, 10 years
measure: Overall mortality
timeFrame: Baseline, 1 year, 2 years, 5 years, 10 years
measure: Breast cancer-specific mortality
timeFrame: Baseline, 1 year, 2 years, 5 years, 10 years
measure: Other exploratory
timeFrame: 12 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: The Department of Oncology, Ullevål, Oslo University Hospital
name: Inger Thune, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.