Trial Governance

The protocol was approved by the Ethics Committee for Research with Medicinal Products of Hospital Clínico San Carlos in Madrid under approval number 24/330-EC_M. The exercise-based physiotherapy interventions are considered non-invasive and minimal risk. Adverse events will be monitored through participant self-report at follow-up assessments. Adverse events are collected at each trial visit and graded with CTCAE v5. Adverse events include unfavourable medical events after intervention receipt whether or not they are related to the intervention. Serious adverse events from radiotherapy start to 30 days after final fraction must be reported to the sponsoring site within 24 hours after the principal investigator becomes aware. Blinding may be broken when allocation knowledge is needed for optimal clinical care during serious haemorrhagic or thromboembolic events. No data safety and monitoring committee will be established because adverse events are not considered a major concern.