Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2020-09-08
2023-03-02
Brief Summary
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Detailed Description
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The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Aerobic Exercise
The aim is for participants to complete three weekly sessions of supervised aerobic treadmill based exercise for five months. Session duration varies from 20-60 minutes, with exercise intensity ranging from 55-95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate), will be determined by the CPET performed by certified exercise physiologists at baseline.
Aerobic Exercise
Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
Standard care
Participants in this arm will not receive any follow-up on exercise during the intervention period.
No interventions assigned to this group
Reference Group
Participants in this arm are age-matched women with no history of any malignant disease, which will undergo similar assessments at baseline and post-intervention and also follow similar exercise intervention as the breast cancer survivors randomized to the Aerobic exercise arm
Aerobic Exercise
Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
Interventions
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Aerobic Exercise
Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
Eligibility Criteria
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Inclusion Criteria
* Female
* Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012
* 60 years or younger at the time of diagnosis
* received anthracycline-based chemotherapy as a part of their treatment history
* signed informed consent and medical doctors approveal of participation prior to inclusion
Exclusion Criteria
* Diagnosed with stage IV breast cancer
* Relapse since diagnosis
* A history, or current presence, of another diagnosis of invasive cancer of any kind
* Selfreported severe fatigue
* present with any uncontrolled- or recent cardiovascular disease, has undergone heart surgery or uses a pacemaker
* currently exercising more than 90 minutes per week
28 Years
72 Years
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
University of Oslo
OTHER
Norwegian School of Sport Sciences
OTHER
Responsible Party
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Tormod Skogstad Nilsen
PhD
Principal Investigators
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Tormod S Nilsen, PhD
Role: PRINCIPAL_INVESTIGATOR
The Norwegian School of Sport Sciences
Locations
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Norwegian School of Sport Sciences
Oslo, , Norway
Countries
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References
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Hassing Johansen S, Reinertsen KV, Wisloff T, Saeter M, Sarvari SI, Kiserud CE, Strandos N, Edvardsen E, Grydeland M, Nilsen TS, Thorsen L. Effects of aerobic exercise on late effects and quality of life in Long-Term breast cancer survivors: a randomized controlled trial. JNCI Cancer Spectr. 2025 Oct 21:pkaf102. doi: 10.1093/jncics/pkaf102. Online ahead of print.
Saeter M, Johansen SH, Reinertsen KV, Thorsen L, Haugaa KH, Nilsen TS, Sarvari SI. Cardiorespiratory fitness, cardiac morphology and function, and cardiovascular risk factors in long-term breast cancer survivors compared with non-cancer controls. Cardiooncology. 2025 Jan 4;11(1):1. doi: 10.1186/s40959-024-00296-0.
Nilsen TS, Saeter M, Sarvari SI, Reinertsen KV, Johansen SH, Edvardsen ER, Hallen J, Edvardsen E, Grydeland M, Kiserud CE, Lie HC, Solberg PA, Wisloff T, Sharples AP, Raastad T, Haugaa KH, Thorsen L. Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 15;12:e45244. doi: 10.2196/45244.
Other Identifiers
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2019/1318
Identifier Type: -
Identifier Source: org_study_id
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