Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2)
ConditionSwallowing Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHopital Forcilles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to Hôpital Forcilles for head and neck cancer radiotherapy;
Ultrasound operator available ;
Patient at least 18 years old at the time of inclusion;
Membership of a social security scheme or beneficiary of such a scheme ;
Disqualifiers
Patients with neurological disorders;
Patients with DR before the start of radiotherapy;
Patient's refusal to participate in the study ;
Person subject to a safeguard of justice measure ;
Trial population
The study will enroll 124 outpatients initiating head and neck cancer radiotherapy at Forcilles's Hospital over eighteen months. All eligible consecutive patients will undergo screening at admission and provide oral consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Swallowing disorders will be diagnosed by videofluoroscopy wich will be performed when swallowing disorder is suspected or at the end of radiotherapy treatment.
Time frame
On the day of the initial radiotherapy session, preceding the treatmentSecondary outcomes
1
Inter and intra-rater evaluation
Repeated measurements by the same ultrasonographer and by a second ultrasonographer on a concurrent sample
Time frame
On the day of the initial radiotherapy session, preceding the treatment2
To describe the changes in ultrasound measurements after 5 and 10 sessions of radiotherapy
Ultrasound evaluations will be performed at inclusion and 7 and 14 days afterward to assess and describe changes in ultrasound measurements related to radiotherapy after 7 and 14 days of treatment
Time frame
On the day of the initial radiotherapy session and 7 and 14 days afterwardOther outcomes
1
Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development
Ultrasound evaluation will be performed at inclusion and 7 and 14 days afterward to evaluate the predictive capacity of observed changes in ultrasound to anticipate the development of swallowing disorders during radiotherapy treatment
Time frame
Sevent and fourteen days afterward the first ultrasound assessment2
Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy.
Ultrasound evaluation will be performed on the day of the initial radiotherapy session, preceding the treatment. Incidence is defined as the proportion of new cases of undernutrition during radiotherapy
Time frame
On the day of the initial radiotherapy session, preceding the treatment3
Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy.
Ultrasound evaluation will be performed at inclusion and 7 and 14 days afterward to evaluate the predictive capacity of observed changes in ultrasound to anticipate new cases of undernutrition during radiotherapy Incidence is defined as the proportion of new cases of undernutrition during radiotherapy
Time frame
On the day of the initial radiotherapy session, preceding the treatment4
Predictive capacity of ultrasound markers for anticipating quality of life assessed by the MD Anderson Dysphagia Inventory questionnaire at 30 days of radiotherapy treatment
Predictive capacity of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound and quality of life at 30 days of radiotherapy treatment assessed by the MD Anderson Dysphagia Inventory questionnaire
Time frame
At 30 days of radiotherapySponsors and contacts
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Source ClinicalTrials.gov