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

NCT03632200 | Unknown

• 1 other identifier: PI2018_843_0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Disorders; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• The satisfactory nutritional state defined by the absence of loss of weight

  weight loss difference equal to 0 between the time 0 and the 6th month

  6 months

Secondary Outcomes (1)

• The score PG-SGA (index of Detsky)

  6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Experimental group

Control group

NO INTERVENTION

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

Interventions

Experimental group OTHER

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

Also known as: multidisciplinary specific consultation

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Nutrition Disorders; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Stéphanie Dakpé, MD

  CHU Amiens Picardie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Dakpé, MD

CONTACT

+330322089080; dakpe.stephanie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a pilot study to compare experimental group (improved coverage) and control group (classic coverage)

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 15, 2018
• Study Start: March 21, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)