Energy Balance and Breast Cancer Aspects-II

NCT02240836 | Active Not Recruiting DMC

• 1 other identifier: 2014/945-1
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 2

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.

Conditions

DCIS Grade 3; Stage I Breast Cancer; Stage II Breast Cancer; LCIS, Lobular Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• VO2max

  Change in VO2max from baseline to 12 months

  Baseline,12 months

Secondary Outcomes (17)

• BMI

  Baseline,12 months

• Systolic blood pressure

  Baseline,12 months

• Diastolic blood pressure

  Baseline,12 months

• Total cholesterol

  Baseline,12 months

• LDL cholesterol

  Baseline,12 months

Other Outcomes (8)

• Respiratory Quotient (RQ)

  12 months

• Lactate

  12 months

• HRmax

  12 months

Study Arms (2)

Intervention. Exercise

EXPERIMENTAL

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

Control group

NO INTERVENTION

Control group, standard treatment regimen

Interventions

Intervention. Exercise OTHER

Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.

Also known as: Physical activity

Intervention. Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator
• The Research Council of Norway: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, Norway

Location

St. Olavs Hospital

Trondheim, 7000, Norway

Location

Related Publications (9)

• 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.

  PMID: 9701097 BACKGROUND

• 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.

  PMID: 12525233 BACKGROUND

• 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.

  PMID: 15292387 BACKGROUND

• 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.

  PMID: 14744958 BACKGROUND

• 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.

  PMID: 24633595 BACKGROUND

• 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.

  PMID: 20159820 BACKGROUND

• 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.

  PMID: 25144625 BACKGROUND

• 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.

  PMID: 24454832 BACKGROUND

• 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.

  PMID: 24419734 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Inger Thune, MD. PhD

  The Department of Oncology, Ullevål, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: October 31, 2017
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

NO (2)