Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients
- Conditions
- Breast cancer, cardiotoxicity, physical exercise
- Registration Number
- NL-OMON21174
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU) in collaboration with the Nederlands Cancer Institute (Antoni van Leeuwenhoek)
- Brief Summary
PACT:<br> Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Medicine. 2015;13:121 <br><br> PACES: <br> van Waart H, Stuiver MM, van Harten WH, Geleijn E, Kieffer JM, Buffart LM, de Maaker-Berkhof M, Boven E, Schrama J, Geenen MM, Meerum Terwogt JM, van Bochove A, Lustig V, van den Heiligenberg SM, Smorenburg CH, Hellendoorn-van Vreeswijk JA, Sonke GS, Aaronson NK. Effect of Low-Intensity Physical Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion Rates: Results of the PACES Randomized Clinical Trial. J Clin. Oncol. 2015; 33(17):1918-27
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 180
Patients who participated in the previous PACT or PACES study (PACT = NTR2138, PACES = NTR2159).
- Participants who died during follow-up
- Participants who are not considered eligible by their treating physician, based on psychological or physiological contraindications.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Extracellular volume fraction (ECV)as detected with cardiac MRI using quantitative mapping techniques.
- Secondary Outcome Measures
Name Time Method 1. Cardiac MRI parameters other than ECV; such as LVEF and global longitudinal strain<br /><br>2. Cardiopulmonary exercise testing (CPET) parameters, including VO2 peak<br /><br>3. Resting echocardiography<br /><br>4. Stress echocardiography (post-exercise)<br /><br>5. Endothelial function, as measured by the EndoPAT. <br /><br>6. Muscle strength<br /><br>7. Congitive functioning incl. self-reported cognitive complaints<br /><br>8. Biochemical measurements regarding exercise-related and cardiovacular toxicity biomarkers<br /><br>9. Quality of life, depression and anxiety, fatigue