gms | German Medical Science

Background and status of (inter)national research: In 2011, Muscaritoli et al. proposed a novel metabolic approach of integrating lifestyle measures aimed at optimizing the nutritional and metabolic state of cancer patients beginning at the time of diagnosis. However, ten years later, only a very limited number of studies have examined lifestyle intervention strategies during systemic cancer therapy, and no study has investigated the combined effects of a personalized nutrition and physical activity intervention with systemic therapy. Here, we present the INTEGRATION program, a multicenter randomized clinical trial that aims to fill this gap by establishing and scientifically evaluating a structured, individualized lifestyle program delivered parallel to systemic cancer therapy.

Question and objective: This study will investigate the efficacy and feasibility of a structured nutrition and exercise program among oncologic patients receiving first-line systemic cancer therapy.

Method: In this multicenter, randomized controlled trial, 472 newly diagnosed adult cancer patients undergoing systemic first-line therapy will be recruited at eleven cancer centers throughout Germany. Upon agreeing to participate, individuals will be randomized to either the intervention group providing the novel care program or the control group providing usual care. The intervention group will receive regular individualized nutrition counseling (at least bi-weekly) and an intensive individualized physical activity training program (two times per week) during systemic cancer treatment for up to a maximum of six months. The control group will continue to receive usual care during this period. Patients from both groups will be evaluated at baseline and at pre-defined time intervals over a period of 18 months using a panel of established assessment tools, which will result in an individual resource-oriented needs analysis (RoBa). The RoBa score is calculated based on a combination of needs-based assessments derived from a carefully considered, equally distributed combination of validated parameters from the fields of nutrition, physical activity and quality of life. Within this score, the patients’ nutritional status is determined by body-mass-index, weight-to-height-ratio, patient-generated subjective global assessment (PG-SGA), bioelectrical impedance analysis (BIA) and modified Glasgow prognostic score (mGPS). The physical activity status is assessed by a hand-grip strength test, an unipedal stance assessment, spiroergometry and a seven-day accelerometer measurement. Four validated questionnaires (MFI-20, FACT/GOG-Ntx, HADS and SF-36) are used to assess quality of life. All assessments are equally weighted and consist of three resource or deficit categories (0, 1 or 2), of which 0 represents the highest individual resource and lowest deficit, and 2 the opposite. The primary endpoint of this study is the reduction of needs (i.e., strengthening of resources) at the end of primary cancer treatment no later than 6 months after treatment onset.