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Clinical Trial
. 2022 Dec 21;23(1):1036.
doi: 10.1186/s13063-022-06991-6.

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  1 , André Van Gossum  2 , Frederic Duprez  3 , Yassine Lalami  4 , Yolene Lefebvre  5 , Sofiana Mootassim-Billah  6 , Sylvie Beauvois  7 , Akos Gulyban  8 , Christophe Vandekerkhove  8 , Petra Boegner  9 , Marianne Paesmans  10 , Lieveke Ameye  10 , Antoine Digonnet  11 , Marie Quiriny  11 , Didier Dequanter  12 , Samuel Lipski  11 , Esther Willemse  11 , Alejandra Rodriguez  12 , Sebastien Carlot  13 , Yasemin Karaca  14 , Marc Lemort  5 , Patrick Emonts  5 , Clémence Al Wardi  15 , Dirk Van Gestel  7
Affiliations
Clinical Trial

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 et al. Trials. .

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.

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

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Patient-reported outcomes
See this image and copyright information in PMC

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