Journal: Future science OA
This publication outlines the protocol for a multicenter, randomized controlled trial assessing the efficacy of a personalized, combined nutritional and physical exercise intervention alongside first-line cancer treatment.
The study will enroll 472 patients randomized into two arms:
- Intervention group: receiving a supervised, individualized nutrition and exercise program for 4 to 6 months.
- Control group: provided with non-supervised physical activity recommendations and nutrition counseling.
Outcomes including physical and nutritional status, as well as quality of life, will be evaluated using a resource-oriented needs assessment (RONA) at multiple time points.
The primary endpoint is a reduction in the need for supportive care, measured by the RONA score, at the end of cancer treatment or after six months of intervention.