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RecruitingNCT03632200NUTRIMAXUpdated May 13, 2026

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

An interventional study of Experimental group in Nutrition Disorders and Head and Neck Cancer, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nutrition Disorders
  • Head and Neck Cancer
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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

  • No intervention
    Control group

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

Interventions

  • OtherExperimental group

    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

05

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. The score PG-SGA (index of Detsky)

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • CHU Amiens-Picardie
    Amiens, France
    • Dakpé Stéphanie, MD · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03632200
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Aug 15, 2018
Start date
Mar 21, 2019
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
May 13, 2026

Study contacts

Stéphanie Dakpé, MD
Contact
dakpe.stephanie@chu-amiens.fr
+330322089080
Stéphanie Dakpé, MD
principal investigator · CHU Amiens Picardie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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