The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspiration and Preservation of Swallowing (PREHAPS): study protocol of a monocentric prospective randomized interventional outcome-blinded trial.

BACKGROUND: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable. METHODS: The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Seventy patients (30 control group, 30 intervention group, 10 drop-out rate of 15%) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both detailed subjective assessment of swallowing function and quality of life by means of various questionnaires and objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: detailed counseling with video demonstration and exercises to strengthen and improve the range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed at 6 weeks, 3 and 6 months, and 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary study endpoints are swallowing function and emotional distress at 6 weeks of control visit. DISCUSSION: Prehabilitation measures have already proven successful in other patient groups, e.g., transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually, only subgroups, e.g., patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life. TRIAL REGISTRATION: German Clinical Trials Register DRKS00029676 . International Clinical Trials Registry Platform DRKS00029676 . Registered on 19 July 2022.

Prehabilitation of dysphagia in the therapy of head and neck cancer- a systematic review of the literature and evidence evaluation.

Background: Prehabilitation is becoming increasingly important in oncology because of the significant survival benefits that the reduction of malnutrition provide. Specifically, tumor- and therapy-related dysphagia leads to malnutrition in more than half of head and neck tumor patients. Studies describe the positive effects of an early onset of swallow-specific prehabilitation on the protection of the swallowing function. This paper intents to evaluate the existing evidence on the efficacy of preventive forms of swallowing therapy. Methods: A systematic literature search was performed in February 2022 in the Cochrane Library, MEDLINE via PubMed, and ClinicalTrials.gov databases for randomized controlled trials investigating preventive swallowing therapy in head and neck tumor patients. This Procedure complies with the PRISMA statement. The RCTs were evaluated by using the PEDro Scale and the Cochrane Risk of Bias tool RoB2. Results: Five randomized-controlled trials with 423 participants were identified. Four Studies showed moderate to high quality in the PEDro analysis, one showed less. The risk of bias was high in all studies because there was no possibility for blinding and there were high dropout rates. Heterogeneity in interventions, measurement instruments, measurement time points, and outcomes limits a general statement about which swallowing exercises are suitable for the prevention of dysphagia in head and neck tumor patients. Evidence is provided for short-term effects (≤24 months) on functional aspects of swallowing and quality of life. Overall, a decreasing adherence over time was observed in the intervention groups. Discussion: Initial studies describe swallowing-specific prehabilitation programs in head and neck tumor patients as effective, at least in the short term, whereas long-term effects need to be further investigated. At the current time the evidence base for clear recommendations does not appear to be sufficiently high and studies share a high risk of bias. Further well-designed research, especially considering the conditions in the national health care system, is needed. Other: There was no funding and no registration.