NCT03632200 Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
| NCT ID | NCT03632200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Nutrition Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-03-21 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2019-03-21 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stéphanie Dakpé, MD
PRINCIPAL INVESTIGATOR
CHU Amiens Picardie
Frequently Asked Questions
Who can join the NCT03632200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Nutrition Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03632200 currently recruiting?
Yes, NCT03632200 is actively recruiting participants. Contact the research team at dakpe.stephanie@chu-amiens.fr for enrollment information.
Where is the NCT03632200 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT03632200 clinical trial?
NCT03632200 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Stéphanie Dakpé, MD at CHU Amiens Picardie. The trial plans to enroll 60 participants.