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

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

Head and neck cancer patients treated with concomitant chemoradiotherapy involving the oral cavity and oropharynx: is another choice possible than prophylactic gastrostomy?

“…The key considerations include the main treatment goals of oncologists, focusing on locoregional control and survival, contrasted with the concerns of nutritionists who emphasize weight loss and swallowing difficulties [8]. A recently published ongoing trial seeks to compare prophylactic gastrostomy vs. reactive gastrostomy in terms of their impact on swallowing function [13 ▪ ]. The potential risk is that a technique deemed essential in specific situations might be at risk of fading away due to these contrasting viewpoints.…”

Multidisciplinary survey on use of feeding tubes in head and neck cancer patients undergoing chemoradiotherapy in Germany—the SUFEETUBE project

“…Accordingly, there are not only several studies on its prevention [ 7 , 8 ], but also on the correct timing of PEG tube insertion. The Swall PEG study is particularly noteworthy here [ 12 ]: as a randomized, controlled phase III study, its primary endpoint investigated patient-reported outcomes related to swallowing and patients’ health-related quality of life. The authors have announced their intention to publish their results in a peer-reviewed journal [ 12 ].…”

“…The Swall PEG study is particularly noteworthy here [ 12 ]: as a randomized, controlled phase III study, its primary endpoint investigated patient-reported outcomes related to swallowing and patients’ health-related quality of life. The authors have announced their intention to publish their results in a peer-reviewed journal [ 12 ]. Other efforts address the avoidance of radiation-associated dysphagia by means of optimized radiation planning (dysphagia-optimized intensity-modulated radiotherapy) with dose constraints to the superior and middle pharyngeal constrictor muscle or inferior pharyngeal constrictor muscle up to a mean dose of 50 Gy.…”

“…The question of the correct timing of a PEG tube and its influence on the patients’ quality of life including patient-reported outcomes was investigated in the so-called Swall PEG study, a phase III trial. The results have not yet been published [ 12 ].…”