Head and Neck Cancer Clinical Trial
Official title:
Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy
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.
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