Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

Study Overview
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Brief Summary
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This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.

Official Title
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Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

Conditions
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Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy

Intervention / Treatment
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* Radiation: Tomotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (e) old (e) over 18 years Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven. Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum) Indication of head and neck radiotherapy bilateral All of the TNM stage except metastatic Patient has signed informed consent for participation in the study Mastery of the French language Exclusion Criteria: History of head and neck radiotherapy Indication of head and neck radiotherapy unilateral Personal history of malignant tumors uncontrolled over the past 5 years History of oral sicca syndrome Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland) Concomitant treatment with amifostine Concomitant treatment with cetuximab Primary tumor of the salivary glands Head and neck hyperfractionated radiotherapy and / or accelerated Head and neck radiotherapy hypofractionated Metastatic disease Patient deprived of liberty, under guardianship Any medical condition or psychological associate that could compromise the patient's ability to participate in the study Refusal of the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Tomotherapy|Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with xerostomia | Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy. | 12 months after completion of radiotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of acute and late xerostomia | Evaluation of acute xerostomia | after 3, 6 and 12 months after radiotherapy | 
| Measurement of salivary flow with and without stimulation | Measurement of salivary flow with and without stimulation | at 3, 6 and 12 months after end of radiotherapy | 
| Evaluation of the incidence of acute side effects of radiotherapy | Evaluation of the incidence of acute and late side effects of radiotherapy | Weekly during radiotherapy | 
| Evaluation of the incidence of late side effects of radiotherapy | Evaluation of the incidence of late side effects of radiotherapy | At 3, 6 and 12 months after radiotherapy | 
| Evaluation of quality of life and fatigue | Evaluation of quality of life and fatigue | At 3, 6 and 12 months after radiotherapy | 
| Evaluation of overall survival and progression-free survival | Evaluation of overall survival and progression-free survival | at 3, 6 and 12 months after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tomotherapy, xerostomy, head and neck squamous cell carcinoma