Study Design and Participants
dysphagia, TNM7, toxicity, squamous cell carcinoma of the oropharynx, carcinoma, Oropharyngeal cancer, cognitive or language deficits, Cancer
DYSPHAGIA, METASTASIS, CARCINOMA, OROPHARYNGEAL CANCER, CANCER
The PRophylactic Swallowing Exercise Therapy program for patients with Oropharyngeal cancer (PRESTO) was a multicenter, open-label randomized controlled trial. Patients were enrolled at four Belgian hospitals (University Hospitals of Antwerp, Ghent and Leuven and General Hospital Sint-Jan Bruges).Patients with a stage III or IVA-B (TNM7) newly diagnosed squamous cell carcinoma of the oropharynx were prospectively recruited for this study. Candidates for enrollment were both men and woman older than 18 years, with no cognitive or language deficits that might interfere with the correct implementation of the swallowing therapy protocol. Patients were treated with 6–7 weeks fractionated RT/CRT with or without induction chemotherapy. Exclusion criteria were the presence of a recurrent carcinoma or metastasis from a non-HNC carcinoma and previous RT/CRT or surgery in the head-neck region with possible impact on swallowing function. Written informed consent was obtained from all participants.The minimization program QMinim was used to randomly assign all participants with a 1:1:1 allocation to one of the three exercise groups: diary-supported PSE (paper group), app-supported PSE (app group) and therapist-supported PSE (therapist group). The minimization factors were age (20–60 vs. ≥ 60 years old), treating center, presence of baseline dysphagia and treatment (radiotherapy or concomitant chemoradiotherapy). The three groups differed in degree and kind of adherence-improving measures. All patients performed the same PSE program 5 times a week during the first 4 weeks of RT/CRT. Limiting the therapy program to the first 4 weeks of RT/CRT was a general measure to maximize adherence since acute toxicity typically peaks during week 5 of radiotherapy treatment [Iowa Oral Performance Instrument (model 3.2, IOPI Medical LLC, Woodinville, WA, USA)Swallowing Exercise Aid (Antoni Van Leeuwenhoek, Netherlands Cancer Institute)