NCT03850171

Cancer Adverse Effects PReventIon With Care & Exercise: the CAPRICE Study

Terminated NA Last updated 27 February 2023

What this trial tests

NA trial testing Exercise Training in Breast Neoplasm Female in 57 participants. Terminated before completion.

Timeline

1 May 2019

Primary endpoint
31 December 2022

31 January 2023

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	57
Start date	1 May 2019
Primary completion	31 December 2022
Estimated completion	31 January 2023
Sites	4 locations across Switzerland

Drugs / interventions tested

• Exercise Training

Conditions studied

• Breast Neoplasm Female — all drugs for Breast Neoplasm Female →
• Lymphoma — all drugs for Lymphoma →
• Cardiotoxicity — all drugs for Cardiotoxicity →
• Anthracyclines — all drugs for Anthracyclines →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Breast Neoplasm Female or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Cardioprotection in Cancer Therapy Cardiotoxicity: <i>JACC: CardioOncology</i> State-of-the-Art Review.
   Omland T, Heck SL, Gulati G. · · 2022 · cited 113× · PMID 35492815 · DOI 10.1016/j.jaccao.2022.01.101
2. Supervised exercise training in patients with cancer during anthracycline-based chemotherapy to mitigate cardiotoxicity: a randomized-controlled-trial.
   Schneider C, Ryffel C, Stütz L, Rabaglio M, et al · · 2023 · cited 7× · PMID 38111886 · DOI 10.3389/fcvm.2023.1283153
3. Evidence-based prediction and prevention of cardiovascular morbidity in adults treated for cancer.
   Altena R, Hubbert L, Kiani NA, Wengström Y, et al · · 2021 · cited 6× · PMID 34049593 · DOI 10.1186/s40959-021-00105-y
4. Effect of supervised exercise training on objectively measured physical activity in patients during anthracycline therapy.
   Schneider C, Stuetz L, Dierks A, Campbell KL, et al · · 2024 · PMID 41878657 · DOI 10.1016/j.jsampl.2024.100075