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

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.

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Publication Details

Journal
Future Science OA
Published
2025-10-09
DOI
https://doi.org/10.1080/20565623.2025.2564607
Primary Topic
Nutrition and Health in Aging
Type
article
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article

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

Michael Neumann, Annika Tomanek, Katrin Fuhse, Cordula Riederer et al.
Future Science OA
Nutrition and Health in Aging
article

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

Michael Neumann, Annika Tomanek, Katrin Fuhse, Cordula Riederer, Barbara Scheerer, Timo Niels, Hansjörg Baurecht, Joachim Wiskemann, Luisa Samland, Patrick Jahn, Katharina Graf, Ingeborg Rötzer, Sebastian Theurich, Verena Wegmann, Nicole Erickson, Jann Arends, Ingo GH Schmidt-Wolf, Diana Klassen, R. Fischer, Nora Zoth, Johann Ockenga, Kim Barbara Luley, Elke Jäger, Dirk Forstmeyer, Freerk T. Baumann, Ulrich Hacker, Hartmut Bertz, A. Mumm, Martin Halle, Caterina Fiorentini, Lutz Müller, Christine Greil, Christine Welker, Marianne Sinn, Jana Müller, Götz Dimanski, W. Jensen, Michael Leitzmann, Bernadine Madl, Thomas Jaschinski-Weber, Marion Hammling, Helén Frostbrant-Bake
article en

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.

Future Science OAVol. 11(1)
Goethe University Frankfurt (DE), Kubota (Japan) (JP), Universität Hamburg (DE), German Cancer Research Center (DE), Heidelberg University (DE), University Hospital Bonn (DE), Luther University (KR), University Hospital Heidelberg (DE), TUM Klinikum (DE), University Medical Center (US), LMU Klinikum (DE), AOK (DE), Düsseldorf University Hospital (DE), Verband der Privaten Krankenversicherung (DE), Integrated Oncology (United States) (US), University Medical Center Hamburg-Eppendorf (DE), National Center for Tumor Diseases (DE), University Hospital Schleswig-Holstein (DE), University Cancer Center Hamburg (DE), Mammazentrum Hamburg (DE), University Hospital Frankfurt (DE), Krankenhaus Nordwest (DE), Stem Cell Institute (PA), Klinikum Bremen-Mitte (DE), Deutsche Rentenversicherung Bund (DE), Heinrich Heine University Düsseldorf (DE), University of Regensburg (DE), Martin Luther University Halle-Wittenberg (DE), Ludwig-Maximilians-Universität München (DE), Leipzig University (DE), University of Lübeck (DE)
Openalex Percentile: Top 64%
Nutrition and Health in Aging
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