Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2)

NCT06387004 | Recruiting DMC

• 1 other identifier: 2023-A01971-44
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Swallowing Disorders

Keywords

Swallowing disorders; Echography; Prediction model; head and neck cancer

Outcome Measures

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.

  On the day of the initial radiotherapy session, preceding the treatment

Secondary Outcomes (2)

• Inter and intra-rater evaluation

  On the day of the initial radiotherapy session, preceding the treatment

• To describe the changes in ultrasound measurements after 5 and 10 sessions of radiotherapy

  On the day of the initial radiotherapy session and 7 and 14 days afterward

Other Outcomes (5)

• Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development

  Sevent and fourteen days afterward the first ultrasound assessment

• Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy.

  On the day of the initial radiotherapy session, preceding the treatment

• Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy.

  On the day of the initial radiotherapy session, preceding the treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Patients admitted to Hôpital Forcilles for head and neck cancer radiotherapy;
• Ultrasound operator available ;
• Membership of a social security scheme or beneficiary of such a scheme ;
• Oral, free, informed and express patient consent.

You may not qualify if:

• 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 ;
• Patient under guardianship;
• Patient with limited care.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, 77150, France

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• DIAZ LOPEZ Carlos, PhD st

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

• LE NEINDRE Aymeric, PhD

  Hopital Forcilles

  STUDY DIRECTOR

• Medina i Mirapeix Francesc

  Universidad de Murcia

  STUDY DIRECTOR

Central Study Contacts

LE NEINDRE Aymeric, PhD

CONTACT

+33160646093; aleneindre@cognacq-jay.fr

DIAZ LOPEZ Carlos, PhD st

CONTACT

0160646130; cdiaz.physio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 26, 2024
• Study Start: January 18, 2024
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

FR (1)