Mouth Opening, Prevention, Education, Nutrition (OPEN)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Trismus prevalence — 10 weeks after the end of radiochemotherapy
  The mouth opening is measured by the distance between the upper left median incisive (n°21) and the lower left median incisive (n°31) with the Therabite Range of Motion Scale. Trismus is defined as a mouth opening of less than 35mm.

Trial sites (6)

More Institut du Cancer de Montpellier - Val d'Aurelle trials in France

Other trials for the same condition