Etude : NUQUE 3 /

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : NUQUE 3

Situation thérapeutique : Néoadjuvant / Adjuvant

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 19/12/2017
CIM10 - Localisation(s)
Informations principales
Titre : Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C14 - Tumeur maligne de la lèvre, de la cavité buccale et du pharynx, de sièges autres et mal définis

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C30 - Tumeur maligne des fosses nasales et de l'oreille moyenne

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C31 - Tumeur maligne des sinus de la face

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C32 - Tumeur maligne du larynx
Informations complémentaires
Schéma : Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous weight increases the risk of toxicity of the chemotherapy and worsens the patient's quality of life.

The treatment of the tumors of the head and the neck comes along very often with a loss of weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which varies with the chosen treatment, and shows a major risk at the patients whose therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source of aftereffects and late complications: xerostomia, oedemas of mucous membranes.

The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of the patients. It reveals or even increases, a dysphagia. According to Woisard, six months after the end of treatments, forty percent of the patients suffer from a dysphagia.

All these complications limit quantitatively and qualitatively the food intake. The adaptation of the texture of the food is necessary by fifty four percent at three months of the end of treatments according to Logemann et al., and a few patients remain dependent on an long term enteral nutrition.

Beyond a change of the nutritional state, the feeding difficulties or even the absence of resumption of an oral feeding are responsible for a social isolation. The meal which lost its dimension of pleasure becomes a source of fear and obsession for the patient as well as for his relations, and this fact generates family tensions. The quality of life of the patient is heavily affected.

Ravasco showed in his study that the impact on the nutritional state of a nutritional care by dietary advices was more important as the prescription of oral nutritional supplements but based on a short period (the dietary intervention covered only the duration of the radiotherapy). But what would happen after the end of treatments? The investigators emit the hypothesis that a post-therapeutic systematic and regular dietary support has a positive impact on the prevention of the undernutrition among the patients affected by a first cancer of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.

The investigators propose a prospective randomized, open and multicentric study. This study has to include 224 patients affected by a head and neck cancer which therapeutic sequence involves a more or less made sensitized radiotherapy. The beginning of the inclusions is planned for May 2016, the end of inclusion 36 months later.

The nutritional state and quality of life will be evaluated 6 months after radiotherapy.

2 treatment arms:
- Control: Group of patients with standard of care: the nutritional support is conducted by physicians. No systematic dietary support.
- Experimental: Group of patients will benefit from a systematic and regular dietary support. Patients will be followed by a dietitian 1 month and 3 month after radiotherapy in hospital. Then, dietitian will realize a telephon interview 2 and 5 months after radiotherapy.

Phase : NA

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients with first head and neck cancer histologically proved
- Treatment by radiotherapy
- No sign of recidive
- Life expectancy 3-month-old superior
- OMS score < 3
- French speaking

Critères de non-inclusion : - Other former cancer
- Pregnant woman
- No oral feeding before radiotherapy
- Uncontrolled infectious pathology
Informations relatives au promoteur
Promoteur :
CHU de Caen
Type de sponsor : Institutionnel
14000 CAEN

Coordonnateur :
Emmanuel BABIN
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Emmanuel BABIN


Statut de l'essai : CLOS

MAJ : 03/12/2018