Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.

NCT07471451 | Not Yet Recruiting

• 2 other identifiers: RBHP 2025 BATISSE LANCE2025-A02714-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a follow-up study of masticatory function, orofacial functions, and quality of life in patients with a history of upper aerodigestive tract cancer who have undergone rehabilitation with maxillofacial prostheses. The main objective of this study is to evaluate changes in masticatory function during a prosthetic rehabilitation program in patients with a history of upper aerodigestive tract cancer.

Conditions

Head and Neck Cancer

Keywords

mastication; chewing; cancer of the upper aerodigestive tract; prosthetic rehabilitation; oral-facial functions; quality of life; oral health; oral quality of life

Outcome Measures

Primary Outcomes (1)

• Particle size distribution of food bolus collected at the swallowing threshold

  Particle size distribution of food bolus collected at the swallowing threshold for raw carrot samples (CAR), objectified by the D50 value : median value of the particle size of each food bolus

  Baseline (T0) ; T1 (T0 + 3 months) ; T2 (T0 + 1 year)

Study Arms (1)

Prosthetic rehabilitation program

EXPERIMENTAL

Patients with a history of upper aerodigestive tract cancer undergoing prosthetic oral rehabilitation aimed at restoring masticatory function. The evolution of masticatory function is assessed throughout the rehabilitation program.

Procedure: Prosthetic oral rehabilitation

Interventions

Prosthetic oral rehabilitation PROCEDURE

Prosthetic oral rehabilitation to restore oral function in patients with a history of upper aerodigestive tract cancer.

Prosthetic rehabilitation program

Eligibility Criteria

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

You may qualify if:

• Adult patient who has given their consent
• Patient with a history of upper aerodigestive tract cancer
• Cooperative patient
• Patient affiliated with a Social Security scheme
• Patient capable of understanding and participating in the study
• Patient not allergic to the foods being tested

You may not qualify if:

• Minors
• Patients treated in the maxillofacial prosthetics clinic of the Odontology Department at Estaing University Hospital in Clermont Ferrand who do not require prosthetic rehabilitation
• Patients who are unwilling to participate in the study, particularly in attending the various follow-up sessions
• Patients who do not have a good command of written and spoken French
• Patients under guardianship, curatorship, or judicial protection
• Pregnant or breastfeeding patients
• Patients receiving enteral or parenteral nutrition
• Patients who have been diagnosed with a recurrence of their cancer and whose prognosis is life-threatening.
• Patients with cognitive impairment

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Fd

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Cindy BATISSE LANCE

  CHU de Clermont-Fd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)