protocolSection identificationModule nctId: NCT06387004, orgStudyIdInfo id: 2023-A01971-44, briefTitle: Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2), acronym: R-2D-2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2026-02-18, completionDateStruct date: 2026-02-18, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hopital Forcilles, class: OTHER, descriptionModule briefSummary: Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy.Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy., conditionsModule conditions: Swallowing Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 112, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy., secondaryOutcomes measure: Inter and intra-rater evaluation, otherOutcomes measure: Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development, otherOutcomes measure: Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy., otherOutcomes measure: Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy., otherOutcomes measure: Predictive capacity of ultrasound markers for anticipating quality of life assessed by the MD Anderson Dysphagia Inventory questionnaire at 30 days of radiotherapy treatment, otherOutcomes measure: Ratio of ultrasound measurements of tongue, hyoid bone, and suprahyoid muscle morphology and/or movement successfully conducted, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Forcilles, status: RECRUITING, city: Férolles-Attilly, zip: 77150, country: France, contacts name: Aymeric Le Neindre, PhD, role: CONTACT, phone: +33160646093, email: aleneindre@cognacq-jay.fr, contacts name: Carlos DIAZ LOPEZ, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.73184, lon: 2.63088, hasResults: False