Mouth Opening, Prevention, Education, Nutrition (OPEN)
Mouth Opening, Prevention, Education, Nutrition (OPEN)
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.
The management of trismus and its side effects is essentially based on a re-education of
 maxillary constrictions to limit or reduce the loss of mouth opening in patients. Exercise
 protocols are in place and have been evaluated in the literature with discordant results. The
 beneficial effect of a rehabilitation program on the prevalence of trismus, oral opening and
 quality of life of patients is not yet clearly demonstrated.

 Three studies did not show any significant beneficial effect of rehabilitation programs nor
 on the prevalence of trismus or the quality of life of patients. A 2014 randomized trial
 showed no benefit from a passive exercise program on trismus prevention and oral opening.
 Another 2011 study compared 374 patients, a control group and an intervention group following
 language mobility exercises, rehabilitation supervised by a physiotherapist and specific
 trismus prevention exercises with the help of a doctor. specific tool (Jaw Trainer) during
 and after radiotherapy. A third, more recent, randomized study evaluated the effect of a very
 comprehensive rehabilitation program consisting of a 45-minute session per week of
 rehabilitation with a physiotherapist, 7 exercises to be performed 5 times a day at home
 supplemented by chewing. chewing gum 5 times a day. These last two studies nonetheless
 concluded the importance of carrying out other work on the subject by working on the
 objectives of the studies, on the tools used, and on the implementation of the exercise
 program.

 Also, an other study cited above does not show a significant difference in mouth opening
 between the two rehabilitation groups, but analyzes the adhesion and shows that it is
 significantly higher (59 versus 41 days) in the standard rehabilitation group, less
 burdensome for patients. Thus, the issue of patient adherence to active rehabilitation is
 real and essential to take into account in studies assessing the effect of a rehabilitation
 program on oral opening.

 The prevalence of trismus as well as its management in physiotherapy and the effectiveness of
 a rehabilitation program are not clearly documented in France. Our hypothesis is that
 currently at least 30% of patients treated by radiochemotherapy are affected by a trismus.
 According to national oncology nutrition guidelines, the patients most at risk for
 locoregional complications are those who receive oropharyngeal ≥ 54 Gray radiotherapy doses,
 plus concomitant chemotherapy.

 It seems essential to offer these patients early and preventive management of this symptom
 and its consequences, throughout the duration of treatment.

 This study is all the more relevant as the progress of treatment of upper aero-digestive
 tract cancers have allowed an improvement in survival rates, with an increase in the number
 of patients living with sequelae related to treatments.

 The major benefit for patients will be a decrease in the loss of mouth opening during and
 after treatment, with the consequent improvement of the criteria of well-being and quality of
 life: the resumption of a normal diet, a decrease the duration of artificial nutrition,
 better oral hygiene, improved speech and the recovery of mimicry. All this in order to
 accelerate the return to the most normal social and professional life possible.
Inclusion Criteria:

 -  Epidermoid carcinoma of the buccal cavity, oropharynx or cavum.

 -  Radiotherapy (≥ 54Gy in the oropharynx) and concomitant chemotherapy (including
 targeted therapies) with or without surgery.

 -  Patients ≥ 18 years old, understanding French.

 -  Patients who gave their informed consent prior to the study

 Exclusion Criteria:

 -  Disease and/or trauma with an effect on jaw mobility with permanent trismus.

 -  Psychiatric non-stabilized comorbidity.

 -  Lack of the median and lateral incisors.

 -  Metastatic patient.

 -  Legal inability or limited legal capacity. Medical or psychological conditions
 inducing incapacity of the subject to complete the study or give his/her consent.