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DCIS Grade 3EBBA-IINCT02240836

Energy Balance and Breast Cancer Aspects-II

A study testing Intervention. Exercise in people with DCIS Grade 3 and Stage I Breast Cancer, run by Oslo University Hospital at 2 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Intervention. Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
545 participants
Where
2 sitesNorway
Study dates
Sep 2014to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Oslo University Hospital

    Oslo

  • St. Olavs Hospital

    Trondheim, 7000

Other trials in Norway

About this study

Official title: 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.

Read the 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.
Being tested
Intervention. Exercise
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention. ExerciseOther

    Also called Physical activity

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

Study groups in NCT02240836
Study groupRoleWhat they receive
Intervention. ExerciseExperimentalThe 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
Receives: Other: Intervention. Exercise
Control groupNo interventionControl group, standard treatment regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2max

    Change in VO2max from baseline to 12 months

    Measured: Baseline,12 months

Secondary outcomes (17)

  1. BMI

    Change in BMI from baseline to 12 months

    Measured: Baseline,12 months

  2. Systolic blood pressure

    Change in systolic blood pressure from baseline to 12 months

    Measured: Baseline,12 months

  3. Diastolic blood pressure

    Change in diastolic blood pressure from baseline to 12 months

    Measured: Baseline,12 months

  4. Total cholesterol

    Change in total cholesterol from baseline to 12 months

    Measured: Baseline,12 months

  5. LDL cholesterol

    Change in LDL cholesterol from baseline to 12 months

    Measured: Baseline,12 months

  6. HDL cholesterol

    Change in HDL cholesterol from baseline to 12 months

    Measured: Baseline,12 months

  7. Total cholesterol/HDL cholesterol

    Change in total cholesterol/HDL cholesterol from baseline to 12 months

    Measured: Baseline,12 months

  8. HbA1c

    Change in concentrations of HbA1c from baseline to 12 months

    Measured: Baseline,12 months

  9. Insulin

    Change in concentrations of blood insulin levels (µIU/mL) from baseline to 12 months

    Measured: Baseline,12 months

  10. Triglycerides

    Change in concentrations of triglycerides from baseline to 12 months

    Measured: Baseline,12 months

  11. C-reactive Protein (CRP)

    Change in concentrations of CRP (mg/L) from baseline to 12 months

    Measured: Baseline,12 months

  12. Heart rate

    Change in heart rate from baseline to 12 months

    Measured: Baseline,12 months

  13. Total fat

    Change in total fat from baseline to 12 months

    Measured: Baseline,12 months

  14. Truncated fat

    Change in truncated fat from baseline to 12 months

    Measured: Baseline,12 months

  15. Waist circumference

    Change in waist circumference from baseline to 12 months

    Measured: Baseline,12 months

  16. Energy from food diary

    Change in energy from food diary from baseline to 12 months

    Measured: Baseline,12 months

  17. Metabolic syndrome

    Dichotomous outcome (yes/no)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion31 Oct 2017
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240836
Sponsor's protocol ID
2014/945-1
Acronym
EBBA-II
Status last verified
Apr 2024
First submitted
5 Sep 2014
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9701097

  • 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.

    PubMed 12525233

  • 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.

    PubMed 15292387

  • 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.

    PubMed 14744958

  • 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.

    PubMed 24633595

  • 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.

    PubMed 20159820

  • 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.

    PubMed 25144625

  • 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.

    PubMed 24454832

  • 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.

    PubMed 24419734

Questions about this trial

What is this clinical trial studying?

A study testing Intervention. Exercise in people with DCIS Grade 3 and Stage I Breast Cancer, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2max (time frame: Baseline,12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240836, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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