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

Trials

Study Protocol

André Van Gossum¹  Lieveke Ameye²  Marianne Paesmans²  Samuel Lipski³  Antoine Digonnet³  Esther Willemse³  Marie Quiriny³  Didier Dequanter⁴  Alejandra Rodriguez⁴  Sebastien Carlot⁵  Tatiana Dragan⁶  Dirk Van Gestel⁶  Sylvie Beauvois⁶  Clémence Al Wardi⁷  Sofiana Mootassim-Billah⁸  Patrick Emonts⁹  Marc Lemort⁹  Yolene Lefebvre⁹  Frederic Duprez^1,10  Petra Boegner^1,11  Yassine Lalami^1,12  Christophe Vandekerkhove^1,13  Akos Gulyban^1,13  Yasemin Karaca^1,14 

[1] Consultant at the Department of Gastroenterology and Clinical Nutrition, Hopital Erasme and Institut Jules Bordet, Brussels, Belgium;Data Centre, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Department of Head and Neck Surgery, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium;Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium;Department of Radiation Oncology (Head and Neck Unit), Institut Jules Bordet, Université Libre de Bruxelles, 1 rue Héger Bordet, 1000, Brussels, Belgium;Department of Radiation Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Department of Radiation Oncology, Speech Therapy, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Department of Radiology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Department of Radiotherapy-Oncology, Universitair Ziekenhuis Gent, Gent, Belgium;Medical Oncology Clinic, CHU de Bruxelles, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium;Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium;Medical Physics Department, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium;Stomatology, Oral and Maxillofacial Surgery Department, Erasmus Hospital, Université Libre de Bruxelles, Brussels, Belgium;

关键词: Oropharyngeal squamous cell carcinoma;    Head and neck cancer;    Endoscopic gastrostomy;    Radiotherapy;    Patient-reported outcome;   

DOI  :  10.1186/s13063-022-06991-6

 received in 2021-09-30, accepted in 2022-12-06,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundPercutaneous 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.MethodsPatients 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.DiscussionFindings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation.Trial registrationClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

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