Breast CancerNCT04307407
Exercise in Breast Cancer Survivors
A study testing Aerobic Exercise in people with Breast Cancer, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial 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 Read more about this study
- Who is it for?
- Ages 28 to 72 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteNorway
- Study dates
- 8 Sep 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible BCS must be listed in the Norwegian Cancer registry
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
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
Read the detailed description
In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.
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
- Breast Cancer
- Being tested
- Aerobic Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | 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. Receives: Behavioral: Aerobic Exercise |
| Standard care | No intervention | Participants in this arm will not receive any follow-up on exercise during the intervention period. |
| Reference Group | Other | 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 Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak
Peak oxygen uptake during a treadmill based cardiopulmonary exercise test
Measured: From baseline to five months (post-intervention)
Secondary outcomes (10)
Systolic- and diastolic heart chamber dimensions
Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Measured: From baseline to five months (post-intervention)
Systolic- and diastolic longitudinal strain
Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Measured: From baseline to five months (post-intervention)
Lean body mass
Body composition will be assessed by dual x-ray absorptiometry
Measured: From baseline to five months (post-intervention)
Fat mass
Body composition will be assessed by dual x-ray absorptiometry
Measured: From baseline to five months (post-intervention)
Blood volume
Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method
Measured: From baseline to five months (post-intervention)
Muscle fiber type
Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Measured: From baseline to five months (post-intervention)
Muscle fiber area
Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Measured: From baseline to five months (post-intervention)
Muscle mitochondria mass
Change in mitochondrial proteins will be assessed in muscle biopsies using western blot
Measured: From baseline to five months (post-intervention)
Quality of life: Quality of Life Questionnaire (QLQ) C-30
Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30
Measured: From baseline to five months (post-intervention)
Genome-wide DNA methylation and gene expression
For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA
Measured: From baseline to five months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start8 Sep 2020
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Memorial Sloan Kettering Cancer Center, University of Oslo
- Responsible party
- Principal investigator, Tormod Skogstad Nilsen, Norwegian School of Sport Sciences
- Investigators
- Tormod S Nilsen, PhD, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307407
- Sponsor's protocol ID
- 2019/1318
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41117797Saeter 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.
PubMed 39755716Nilsen 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.
PubMed 36920460
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04307407
- Acronym / sponsor ID
- 2019/1318
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Memorial Sloan Kettering Cancer Center, University of Oslo
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseThe 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 intervention | –Participants in this arm will not receive any follow-up on exercise during the intervention period. |
| Reference Group | Other | Behavioral: Aerobic ExerciseParticipants 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 |
Who may qualify
- Ages
- 28 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible BCS must be listed in the Norwegian Cancer registry
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants 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 | Behavioural | Aerobic Exercise, Reference Group |
Primary outcome
Change in VO2peak
Time frame: From baseline to five months (post-intervention)
Peak oxygen uptake during a treadmill based cardiopulmonary exercise test
10 secondary outcomes
Systolic- and diastolic heart chamber dimensions
Time frame: From baseline to five months (post-intervention)
Systolic- and diastolic longitudinal strain
Time frame: From baseline to five months (post-intervention)
Lean body mass
Time frame: From baseline to five months (post-intervention)
Fat mass
Time frame: From baseline to five months (post-intervention)
Blood volume
Time frame: From baseline to five months (post-intervention)
Muscle fiber type
Time frame: From baseline to five months (post-intervention)
Muscle fiber area
Time frame: From baseline to five months (post-intervention)
Muscle mitochondria mass
Time frame: From baseline to five months (post-intervention)
Quality of life: Quality of Life Questionnaire (QLQ) C-30
Time frame: From baseline to five months (post-intervention)
Genome-wide DNA methylation and gene expression
Time frame: From baseline to five months (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 41117797Johansen 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.
- Derived from this study: PubMed 39755716Saeter 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.
- Derived from this study: PubMed 36920460Nilsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tormod S Nilsen, PhD principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Breast Cancer, run by Norwegian School of Sport Sciences at 1 site 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in VO2peak (time frame: From baseline to five months (post-intervention)). 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 NCT04307407, which also lists 3 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 3 Mar 2023.