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

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 1036
• Main Authors: Dragan, Tatiana, Van Gossum, André, Duprez, Frederic, Lalami, Yassine, Lefebvre, Yolene, Mootassim-Billah, Sofiana, Beauvois, Sylvie, Gulyban, Akos, Vandekerkhove, Christophe, Boegner, Petra, Paesmans, Marianne, Ameye, Lieveke, Digonnet, Antoine, Quiriny, Marie, Dequanter, Didier, Lipski, Samuel, Willemse, Esther, Rodriguez, Alejandra, Carlot, Sebastien, Karaca, Yasemin, Lemort, Marc, Emonts, Patrick, Al Wardi, Clémence, Van Gestel, Dirk
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 21.12.2022; BioMed Central; BMC
• Subjects: Cancer; Cancer therapies; Care and treatment; Chemoradiotherapy - adverse effects; Chemotherapy; Clinical outcomes; Clinical trials; Complications and side effects; Deglutition; Deglutition disorders; Deglutition Disorders - etiology; Deglutition Disorders - prevention & control; Dysphagia; Endoscopic gastrostomy; Endoscopy; Gastrostomy - adverse effects; Gastrostomy - methods; Head & neck cancer; Head and neck cancer; Head and Neck Neoplasms - therapy; Health aspects; Human papillomavirus; Humans; Larynx; Lymphatic system; Metastasis; Oropharyngeal Neoplasms - radiotherapy; Oropharyngeal squamous cell carcinoma; Ostomy; Papillomavirus Infections; Patient outcomes; Patient Reported Outcome Measures; Patient-reported outcome; Patients; Percutaneous endoscopic gastrostomy; Prevention; Quality of Life; Questionnaires; Radiation therapy; Radiotherapy; Risk factors; Squamous cell carcinoma; Study Protocol; Swallowing; Throat cancer; Treatment Outcome; Belgium; Oropharyngeal squamous cell carcinoma; Head and neck cancer; Patient-reported outcome; Endoscopic gastrostomy; Radiotherapy
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06991-6

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