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Clinical Trial Finder

Search Results

Mouth Opening, Prevention, Education, Nutrition (OPEN)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03979924
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

kerstin faravel
Principal Investigator Affiliation Institut régional du Cancer de Montpellier
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Trismus, Head and Neck Cancer
Additional Details

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.

Arms & Interventions

Arms

Other: Interventional Step

The interventional step will comprise the same follow-up as the observational step, except for the addition of an early and preventive care, conducted by a specialized physiotherapist using an active exercise handbook elaborated with the patient's therapeutic education transversal Unit (Utep). This aims at increasing the patient's adhesion to the program and to limit the reduction of mouth opening and its consequences ( Trismus rehabilitation)

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

ONCOGARD, Nîmes, Gard, France

Status

Recruiting

Address

ONCOGARD

Nîmes, Gard, 30900

Site Contact

Antoine SERRE

[email protected]

0430061010 #+33

CHU d'Amiens, Amiens, France

Status

Recruiting

Address

CHU d'Amiens

Amiens, , 80054

Site Contact

Coutte Alexandre, MD

[email protected]

+33467612446

Institut Sainte catherine, Avignon, France

Status

Recruiting

Address

Institut Sainte catherine

Avignon, , 84918

Site Contact

Calderon Benoit, MD

[email protected]

+33467612446

Centre Jean Perrin, Clermont-Ferrand, France

Status

Recruiting

Address

Centre Jean Perrin

Clermont-Ferrand, , 63011

Site Contact

Biau Julian, MD

[email protected]

+33467612446

Montpellier, France

Status

Recruiting

Address

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

Montpellier, , 34298

Site Contact

Marc Ychou, MD, PhD

[email protected]

33-4-6761-3066

CHU de la Réunion, Saint-Pierre, France

Status

Recruiting

Address

CHU de la Réunion

Saint-Pierre, , 97448

Site Contact

Gouya Jéhanne

[email protected]

+33467612446

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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