Personalized Combined Nutrition & Exercise Intervention in Newly Diagnosed Cancer Patients - a Trial Protocol.

Abstract

The prevalences of malnutrition and sarcopenia are high already at the time of cancer diagnosis and significantly impact on treatment outcomes. Here, we present the protocol of a multicenter, randomized controlled trial to evaluate the efficacy of personalized, combined nutrition and physical exercise interventions in parallel to first-line cancer treatment. A total of 472 patients will be included and randomized into one of the two study arms. In the intervention arm (A) patients will receive an individualized, needs-adapted preventive and supervised nutritional and exercise program over at least four and up to six months in parallel to cancer treatment. In the control arm (B), patients receive recommendations for physical activity, prescriptions and nutrition counseling in a non-supervised manner. The physical and nutritional status, as well as quality of life will be analyzed in all patients by a multi-dimensional assessment program, termed resource-oriented needs assessment (RONA), before and at distinct time points during and after the intervention period. The primary combined endpoint will be the reduction of needs for supportive care defined by the RONA score at the end of the first-line cancer treatment or after six months of study intervention whichever comes first.