Exercise in Breast Cancer Survivors
The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
1 other identifier
interventional
210
1 country
1
Brief Summary
The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
September 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2023
CompletedMarch 3, 2023
March 1, 2023
2.5 years
March 6, 2020
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in VO2peak
Peak oxygen uptake during a treadmill based cardiopulmonary exercise test
From baseline to five months (post-intervention)
Secondary Outcomes (10)
Systolic- and diastolic heart chamber dimensions
From baseline to five months (post-intervention)
Systolic- and diastolic longitudinal strain
From baseline to five months (post-intervention)
Lean body mass
From baseline to five months (post-intervention)
Fat mass
From baseline to five months (post-intervention)
Blood volume
From baseline to five months (post-intervention)
- +5 more secondary outcomes
Study Arms (3)
Aerobic Exercise
EXPERIMENTALThe 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.
Standard care
NO INTERVENTIONParticipants in this arm will not receive any follow-up on exercise during the intervention period.
Reference Group
OTHERParticipants 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
Interventions
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
You may qualify if:
- Eligible BCS must be listed in the Norwegian Cancer registry
- Female
- Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012
- years or younger at the time of diagnosis
- received anthracycline-based chemotherapy as a part of their treatment history
You may not qualify if:
- Received Herceptin
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian School of Sport Scienceslead
- Oslo University Hospitalcollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- University of Oslocollaborator
Study Sites (1)
Norwegian School of Sport Sciences
Oslo, 0806, Norway
Related Publications (3)
Johansen SH, 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 Nov 3;9(6):pkaf102. doi: 10.1093/jncics/pkaf102.
PMID: 41117797DERIVEDSaeter 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.
PMID: 39755716DERIVEDNilsen 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.
PMID: 36920460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tormod S Nilsen, PhD
The Norwegian School of Sport Sciences
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
- PhD
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 13, 2020
Study Start
September 8, 2020
Primary Completion
March 2, 2023
Study Completion
March 2, 2023
Last Updated
March 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share