Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study
Tatiana Dragan,
André Van Gossum,
Frederic Duprez,
Yassine Lalami,
Yolene Lefebvre,
Sofiana Mootassim-Billah,
Sylvie Beauvois,
Akos Gulyban,
Christophe Vandekerkhove,
Petra Boegner,
Marianne Paesmans,
Lieveke Ameye,
Antoine Digonnet,
Marie Quiriny,
Didier Dequanter,
Samuel Lipski,
Esther Willemse,
Alejandra Rodriguez,
Sebastien Carlot,
Yasemin Karaca,
Marc Lemort,
Patrick Emonts,
Clémence Al Wardi,
Dirk Van Gestel
Affiliations
Tatiana Dragan
Department of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles
André Van Gossum
Consultant at the Department of Gastroenterology and Clinical Nutrition, Hopital Erasme and Institut Jules Bordet
Frederic Duprez
Department of Radiotherapy-Oncology, Universitair Ziekenhuis Gent
Yassine Lalami
Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles
Yolene Lefebvre
Department of Radiology, Institut Jules Bordet, Université Libre de Bruxelles
Sofiana Mootassim-Billah
Department of Radiation Oncology, Speech Therapy, Institut Jules Bordet, Université Libre de Bruxelles
Sylvie Beauvois
Department of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles
Akos Gulyban
Medical Physics Department, CHU Saint-Pierre, Université Libre de Bruxelles
Christophe Vandekerkhove
Medical Physics Department, CHU Saint-Pierre, Université Libre de Bruxelles
Petra Boegner
Medical Oncology Clinic, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles
Marianne Paesmans
Data Centre, Institut Jules Bordet, Université Libre de Bruxelles
Lieveke Ameye
Data Centre, Institut Jules Bordet, Université Libre de Bruxelles
Antoine Digonnet
Department of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles
Marie Quiriny
Department of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles
Didier Dequanter
Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles
Samuel Lipski
Department of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles
Esther Willemse
Department of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles
Alejandra Rodriguez
Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles
Sebastien Carlot
Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Hospital, Université Libre de Bruxelles
Yasemin Karaca
Stomatology, Oral and Maxillofacial Surgery Department, Erasmus Hospital, Université Libre de Bruxelles
Marc Lemort
Department of Radiology, Institut Jules Bordet, Université Libre de Bruxelles
Patrick Emonts
Department of Radiology, Institut Jules Bordet, Université Libre de Bruxelles
Clémence Al Wardi
Department of Radiation Oncology, Institut Jules Bordet, Université Libre de Bruxelles
Dirk Van Gestel
Department of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles
Abstract Background Percutaneous endoscopic gastrostomy (PEG) is often used to provide nutritional support in locally advanced head and neck cancer patients undergoing multimodality treatment. However, there is little published data on the impact of prophylactic versus reactive PEG. PEG placement may affect swallowing-related physiology, function, and quality of life. The Swall PEG study is a randomized controlled phase III trial testing the impact of prophylactic versus reactive PEG on patient-reported outcomes in terms of swallowing and quality of life in oropharyngeal cancer patients. Methods Patients with locally advanced oropharyngeal cancer receiving chemo-radiotherapy will be randomized to either the prophylactic or reactive PEG tube group. Randomization will be stratified by human papillomavirus (HPV) status and unilateral versus bilateral positive neck lymph nodes. The primary objective of the study is the patient’s reported outcome in terms of swallowing (MD Anderson Dysphagia Inventory (MDADI)) at 6 months. Secondary objectives include health-related quality of life, dosimetric parameters associated with patient-reported outcomes, chemo-radiation toxicities, PEG tube placement complications, the impact of nutritional status on survival and toxicity outcomes, loco-regional control, overall survival, the impact of HPV and tobacco smoking on survival outcomes and toxicities, and the cost-effectiveness of each treatment strategy. Discussion Findings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation. Trial registration ClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019
