Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck (NUTRIMAX)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Nutrition Disorders; Head and Neck Cancer

Treatments: Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT03632200

PI2018_843_0015

Details and patient eligibility

About

Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative.

Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage.

In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months.

In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

Full description

Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative.

Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage.

In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months.

In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients affected by a cancer of the VADS
• Man or woman of 18 and more years old
• Patient benefiting from a surgery for its cancer of the VADS
• Patient having signed a written consent
• Patient member in a national insurance scheme

Exclusion criteria

• Patient minor
• Patient benefiting from a radiotherapy
• Patient participant in another research interfering on the nutritional state of the patient
• Patients under guardianship or guardianship

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental group

Experimental group

Description:

The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in "better to eat". In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5. The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions.

Treatment:

Other: Experimental group

Control group

No Intervention group

Description:

The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP).