Clinical trial · Interventional
Exercise in Breast Cancer Survivors
The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
NCT04307407CI-TRIAL-00064443completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aerobic Exercise
- description
- 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.
- interventionNames
- Behavioral: Aerobic Exercise
- type
- NO_INTERVENTION
- label
- Standard care
- description
- Participants in this arm will not receive any follow-up on exercise during the intervention period.
- type
- OTHER
- label
- Reference Group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDJohansen 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 41117797
- DERIVEDSaeter 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 39755716
- DERIVEDNilsen 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 36920460