Clinical trial NCT03632200: Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
Official title: Improvement of the Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Disorders
Head and Neck Cancer
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a pilot study to compare experimental group (improved coverage) and control group (classic coverage)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The satisfactory nutritional state defined by the absence of loss of weight
timeFrame: 6 months
Secondary outcomes:
measure: The score PG-SGA (index of Detsky)
timeFrame: 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
affiliation: CHU Amiens Picardie
name: Stéphanie Dakpé, MD
role: PRINCIPAL_INVESTIGATOR
References: