Background
Patients with incurable gastroesophageal adenocarcinoma (GAC) experience an impaired health-related quality of life (HRQoL), which might further deteriorate over time. These patients are often confronted with significant life-impacting symptoms, such as fatigue and reduced physical functioning. Exercise combined with nutritional support may improve these outcomes. However, careful evaluation of such an intervention is needed to avoid burdening patients at this vulnerable stage. Therefore, this study aims to evaluate the effects of a combined exercise and nutritional intervention on HRQoL in patients with incurable GAC.
Methods
The RADICES study is a multicenter randomized controlled trial and planning to enroll 196 patients with incurable GAC. Participants are randomly assigned (1:1) to either a patient-tailored intervention or a control group. Patients in the intervention group will receive two supervised training sessions per week and two-weekly nutritional consultations, delivered by trained physiotherapists and dietitians over a 12-week period. The control group will continue to receive standard care, supplemented with general physical activity advice. All patients will receive a Fitbit. As of Dec 12th, 76 patients have been included.
The primary outcome is the between-group difference in HRQoL at 12 weeks, adjusted for baseline HRQoL, measured by the EORTC QLQ-C30 summary score. HRQoL is assessed at baseline, 6, 12 weeks, and every 3 months thereafter up to 1 year. Key secondary outcomes include patient-reported outcomes (including physical functioning, role functioning and fatigue), cardiorespiratory fitness, dietary intake, disease progression, overall survival and cost-effectiveness. Adherence and safety are monitored throughout the intervention period.
Discussion
This study will generate evidence on the effectiveness of a patient-tailored combined exercise and nutritional intervention in patients with incurable GAC. If the intervention shows improvement in HRQoL, it could be integrated into standard care for patients with incurable GAC.
Ms
Linde Huis in 't Veld
(Department of Medical Oncology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands)
Ms
Aniek Bonhof
(Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands)
Dr
Anouk Hiensch
(Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands)
Dr
Nicolette Wierdsma
(Department of Nutrition and Dietetics, Amsterdam UMC, location VUMC, Amsterdam, The Netherlands)
Ms
Sandra Bakker
(Department of Medical Oncology, Zaans Medical Center, Zaandam, The Netherlands)
Mr
Aart Beeker
(Department of Medical Oncology, Spaarne Gasthuis, Hoofddorp, The Netherlands)
Ms
Marjan Davidis-van Schoonhoven
(Department of Medical Oncology, Beatrix Hospital, Gorinchem, The Netherlands)
Ms
Helga Droogendijk
(Department of Internal Medicine, Bravis Hospital, Bergen op Zoom, The Netherlands)
Dr
Jan Drooger
(Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands)
Dr
Joeri Douma
(Department of Medical Oncology, Frisius Medical Center, Leeuwarden, The Netherlands)
Dr
Ruben Goedegebuure
(Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands)
Dr
Nadia Haj Mohammad
(Department of Medical Oncology, Imaging and Cancer, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands)
Dr
Irene van Hellemond
(Department of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands)
Ms
Karin Herbschleb
(Department of Medical Oncology, Sint Antonius Hospital, Nieuwegein, The Netherlands)
Mr
Johan Janssen
(Department of Medical Oncology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands)
Dr
Bianca Mostert
(Department of Medical Oncology, Erasmus MC Cancer Institute University Medical Center, Rotterdam, the Netherlands)
Dr
Marije Slingerland
(Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands)
Dr
Dirkje Sommeijer
(Department of Medical Oncology, Flevo Hospital, Almere, The Netherlands)
Dr
Liesbeth Timmermans
(Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands)
Dr
Arjan Verschoor
(Department of Medical Oncology, Reinier de Graaf Hospital, Delft, The Netherlands)
Dr
Vincent de Weger
(Department of Medical Oncology, Haga Hospital, Den Haag, The Netherlands)
Dr
Harm Westdorp
(Department of Medical Oncology, RadboudUMC, Nijmegen, The Netherlands)
Dr
Miriam Wumkes
(Department of Medical Oncology, Jeroen Bosch Hospital, the Netherlands)
Prof.
Anne May
(Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands)
Prof.
Hanneke van Laarhoven
(Department of Medical Oncology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands)
