Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up study of two previous randomized controlled trials.
- Conditions
- Cardiotoxicitydamage to the heart100192801000629110047066
- Registration Number
- NL-OMON50246
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 185
- All eligible breast cancer participants of the previous PACT and PACES study.
, PACT: physical activity during cancer treatment
PACES: physical activity during adjuvant chemotherapy effectiveness study
- Participants who died during follow-up
- Participants who are not considered eligible by their treating physician,
based on psychological or physiological contraindications.
- Participants treated with systemic therapy or thoracic radiotherapy after
the completion of the original PACT and PACES study for recurrent breast
cancer, including contralateral breast cancer.
- Participants treated with systemic therapy or thoracic radiotherapy after the
completion of the original PACT and PACES study for other malignancies than
breast cancer, excluding non-melanoma skin-cancer.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary outcome will be the difference in increased extracellular volume<br /><br>fraction (ECV) between patients who have participated in a moderate- to<br /><br>high-intensity supervise exercise program (intervention group of PACT and the<br /><br>*On-Track* program of PACES) during adjuvant chemotherapy compared to a<br /><br>combined control group of PACT and PACES. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Left ventricular parameters, other than ECV, measured by CMR<br /><br>- Right ventricular parameters, measured by CMR<br /><br>- Left and right atrial function and geometry measured by CMR<br /><br>- Resting echocardiogram parameters of left and right ventricular function<br /><br>- Post-exercise echocardiogram parameters of left and right ventricular<br /><br>function<br /><br>- Cardiopulmonary exercise testing parameters<br /><br>- Parameters of endothelial function, measured by the EndoPAT<br /><br>- Muscle strength<br /><br>- Quality of life, anxiety and depression and fatigue<br /><br>- Biochemical measurements<br /><br>- Cognitive functioning<br /><br>- Heart rate variability<br /><br>- Physical activity</p><br>