Clinical trial · Interventional
Cancer Adverse Effects PReventIon With Care & Exercise: the CAPRICE Study
Importance of Exercise Training Therapy Timing With Regard to Cardiotoxicity and Patient Preference in Early Breast Cancer and Lymphoma Patients Undergoing Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the lack of financial and human resources the investigators were unable to continue the study. The targeted sample size was not achieved due to recruitment difficulties (mainly related to the Covid-19 pandemic).
Summary
Brief summary (as posted)
Breast cancer is the most common cancer among women worldwide. Similarly, Hodgkin and non- Hodgkin lymphomas make up two of the most prevalent cancers in men and women. Even though remarkable improvements in cancer-free survival have been achieved in the last decades, the development of cardiac toxicity, associated with anthracycline-based chemotherapy (Anth-bC) counteracts the improvements in survival in these patient groups. One of the first clinical manifestation of Anth-bC cardiotoxicity is diastolic dysfunction, with further symptoms being left ventricular dysfunction and heart failure as well as a decline in exercise tolerance. Besides the direct cardiotoxic effects of anticancer treatment, many drugs also have adverse effects on the vascular endothelium. The concept of 'Exercise is Medicine' has become well established in exercise-oncology research. Exercise therapy is now considered a safe and well-tolerated adjunct therapy inducing beneficial effects on body composition, aerobic fitness and muscular strength, pain and fatigue, quality of life (QoL), depressive symptoms, and all cause survival. However, there is insufficient data on the superiority of performing exercise training therapy before and during chemotherapy with regard to cardiotoxic and cardiovascular side effects. Further, there is no data on patient preference for and barriers toward different timings of exercise training therapy. Therefore, the aim of the study is to compare left ventricular (LV) function measured by LV global longitudinal strain (GLS) in breast cancer and lymphoma patients undergoing Anth-bC randomised to completing an exercise-based rehabilitation programme during chemotherapy to those randomised to complete the programme after chemotherapy. Further, blood samples will be drawn to analyse biomarkers of myocardial injury (brain natriuretic peptide and high-sensitive cardiac troponin). Additional measurements include aortic distensibility as part of the echocardiographic examination and exercise capacity through cardiopulmonary exercise testing. QoL and fatigue will be assessed in a questionnaire, compliance with exercise training through monitoring and patient preference at 3 and 6 months will be evaluated through an interview. Cardiovascular risk factors will be assessed through body composition, 24h ambulatory blood pressure monitoring, 24h electrocardiogram and the analysis of established blood markers. Women and men aged 18 years and older with histologically confirmed breast cancer or lymphoma (ECOG grade 0-2) who are Anth-bC naïve and with reasonable life expectancy will be included in the study. The exercise programme is part of onco-rehabilitation programmes at the Inselspital Bern, the Spital AG Thun and the Bürgerspital Solothurn. Programmes last for 12 weeks and offer two supervised sessions per week (@ 60-90 min). They usually contain an endurance component (e.g. 40 min of cycling) and a strength, agility or relaxation component. Patients are encouraged to complete a third exercise session per week at home or elsewhere. Home-based training and general physical activity will be assessed by a questionnaire and an activity monitor. A total of 120 patients will be recruited. Measurements will be performed at baseline, after 3 months (week 13) and after 6 months (week 26).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracyclines | — | UNRESOLVED | — |
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Physical Activity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ExEarly
- description
- Patients completing the exercise training concurrent to anthracycline chemotherapy treatment during months 1 to 3
- interventionNames
- Other: Exercise Training
- type
- NO_INTERVENTION
- label
- ExStandard
- description
- Patients will be encouraged to continue with their regular physical activity routine and will be medically managed as per standard of care by their Cardiologist and Oncologists.
Primary outcomes (1)
- measure
- Changes from baseline in left ventricular (LV) global longitudinal strain (GLS)
- timeFrame
- week 13
- description
- GLS assessed by speckle tracking echocardiography is an established marker for LV systolic function with a good reproducibility, which has also been found in the investigators' laboratory. In breast cancer and lymphoma patients LV global longitudinal strain is an established measure to assess cardiotoxicity of Anth-bC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women and men aged 18 years and older * Histologically confirmed breast cancer or lymphoma * Anth-bC naïve * Scheduled for first-line Anth-bC * Eastern Cooperative Oncology Group (ECOG) grade 0-2 * Curative or palliative approach with reasonable life expectancy * Willingness to attend exercise sessions twice per week for 12 weeks (24 sessions in total) * Informed Consent as documented by signature (Appendix Informed Consent Form) Exclusion Criteria: * Inability to participate in a 3-month training program * Contraindication to maximal CPET * Cancer-specific contraindications including safety blood parameters * Previous radiotherapy of the mediastinum and/or the the left breast * Structural heart disease with reduced left ventricular ejection fraction (EF\<50%) * Valvular heart disease with more than mild regurgitation or stenosis * Heart rhythms other than sinus rhythm * Pacemaker with permanent ventricular stimulation * Antihypertensive medication (e.g. ACE inhibitors/ATII blockers, Ca channel blocker, beta blockers) * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons
References
Publications (2)
- DERIVEDSchneider C, Stuetz L, Dierks A, Campbell KL, Wilhelm M, Eser P. Effect of supervised exercise training on objectively measured physical activity in patients during anthracycline therapy. JSAMS Plus. 2024 Oct 4;4:100075. doi: 10.1016/j.jsampl.2024.100075. eCollection 2024 Dec. PMID 41878657
- DERIVEDSchneider C, Ryffel C, Stutz L, Rabaglio M, Suter TM, Campbell KL, Eser P, Wilhelm M. Supervised exercise training in patients with cancer during anthracycline-based chemotherapy to mitigate cardiotoxicity: a randomized-controlled-trial. Front Cardiovasc Med. 2023 Dec 4;10:1283153. doi: 10.3389/fcvm.2023.1283153. eCollection 2023. PMID 38111886