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Clinical Trials in Norway / NCT02240836
Active, not recruiting Not applicable

Energy Balance and Breast Cancer Aspects-II

NCT02240836 · tracked via the Priya Life Science Norway tracker
Sponsor
Oslo University Hospital
Phase
Not applicable
Started
2014-09
Last updated
2024-04-08

Condition(s) studied

DCIS Grade 3Stage I Breast CancerStage II Breast CancerLCIS, Lobular Carcinoma in Situ

Investigational drug(s) / intervention(s)

Intervention. Exercise

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway
St. Olavs Hospital Trondheim Norway

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02240836 on ClinicalTrials.gov ↗ ← All trials in Norway