2.2. Study Objectives and Eligibility Criteria
HNSCC, head and neck cancer
HEAD AND NECK CANCER
This single-center, exploratory, single-arm prospective study was conducted to evaluate the safety of TESS in patients enrolled and treated between 13 April 2022 and 30 March 2023. Ten patients with locally advanced head and neck cancer who underwent CRT were selected from Hiroshima University Hospital. The eligibility criteria were (1) patients who underwent CRT for head and neck cancer at Hiroshima University Hospital; (2) patients who received 70 Gy of radiation to the laryngopharyngeal area, including the nasopharynx, oropharynx, hypopharynx, or larynx; (3) patients >20 years old at the time of consent; and (4) patients who provided written consent for participation in this study. The exclusion criteria were (1) patients with a history of radiation therapy administration in the head and neck region; (2) patients with a history of tracheostomy; (3) patients with a history of radiation therapy mainly in an area other than the laryngopharyngeal area; (4) patients with pacemakers and implantable cardioverter-defibrillators; (5) patients with difficulty wearing an IFCD on the neck; (6) patients with many inconveniences in daily life (performance status 2 or higher); (7) pregnant and breastfeeding patients and those of reproductive age; and (8) patients who were judged to be inappropriate by the principal investigator or the research coordinator. This study was designed to evaluate the safety and feasibility of TESS using IFCD in patients with HNSCC undergoing CRT. The details of the 10 eligible cases were previously reported [