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ACTIVE NOT RECRUITING
NCT03979924
NA

Mouth Opening, Prevention, Education, Nutrition (OPEN)

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

Summary

In France, 11 316 new cases of upper aero-digestive tract cancer were estimated in 2012. These cancers are treated with a triple-therapy combining surgery, radiotherapy and chemotherapy/targeted therapies. Treatment-induced sequelae are often burdensome: reduction in mouth opening, eventually on to trismus, limitation of lips and tongue mobility, deterioration in oral hygiene, pain due to inflammation and muscle fibrosis. Trismus is defined as a mouth opening of less than 35mm in patients with head and neck cancers. It can be induced by treatments (surgery or radiotherapy) but is also reported at the time of diagnosis, due to the local evolution of the tumour. Management of trismus and its consequences is currently mostly based on physiotherapy of maxillary constrictions in order to limit or decrease the reduction of mouth opening in these patients. Exercise protocols have been set up and evaluated in the literature, but with various results. The benefit of a physiotherapy intervention on trismus prevalence, mouth opening, and patients' quality of life has not yet been shown. Our hypothesis is that at least 30% of patients treated with radiochemotherapy are affected by trismus. According to the nutrition national recommendations in oncology, patients the most at-risk of loco-regional complications are those who receive radiotherapy doses of 54Gy or more in the oropharynx and concomitant chemotherapy. It is thus essential to provide these patients with an early and preventive management of trismus and its consequences, during the whole duration of the treatment.

Official title: Trismus Prevalence and Preventive Rehabilitation Associated With Therapeutic Education for Patients With Head and Neck Cancer Treated With Concomitant Radiochemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2016-10-20

Completion Date

2026-09

Last Updated

2025-02-12

Healthy Volunteers

No

Interventions

BEHAVIORAL

Trismus rehabilitation

The patient will be followed-up by a physiotherapist during all the whole radiotherapy treatment, with short 15-min sessions, twice a week. He/she will be trained to perform regularly and by him/herself the preventive/rehabilitation exercises than the patient will do twice a day until the end of the radiotherapy treatment. The patient will then continue, in an autonomous manner, with his/her rehabilitation. In case of trismus occurrence, the physiotherapist will advise the patient to add a passive tool to the active exercises (Jaw Trainer, Therabite, tongue depressors,…) in order to strengthen the stretching.

Locations (6)

ONCOGARD

Nîmes, Gard, France

CHU d'Amiens

Amiens, France

Institut Sainte catherine

Avignon, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France

CHU de la Réunion

Saint-Pierre, France