NCT03979924Active, not recruiting
Mouth Opening, Prevention, Education, Nutrition (OPEN)
Trismus Prevalence and Preventive Rehabilitation Associated With Therapeutic Education for Patients With Head and Neck Cancer Treated With Concomitant Radiochemotherapy
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 4 Jun 2019
- Start date
- 20 Oct 2016
- Primary completion date
- 6 Feb 2025
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Head and neck cancer
- NCT number
- NCT03979924
What you commit to
- Study type: Interventional
- Participants enrolled: 175
- From 20 Oct 2016 to the primary completion date, 6 Feb 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disease and/or trauma with an effect on jaw mobility with permanent trismus.
- Psychiatric non-stabilized comorbidity.
- Medical or psychological conditions inducing incapacity of the subject to complete the study or give his/her consent.
Other
- Lack of the median and lateral incisors.
- Metastatic patient.
- Legal inability or limited legal capacity.
Who the study is looking for
- Epidermoid carcinoma of the buccal cavity, oropharynx or type 1, 2 or 3 carcinoma of cavum according to the WHO classification.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| ONCOGARD Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| CHU de la Réunion Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.