Nutrition DisordersNUTRIMAXNCT03632200
Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck
A study testing Experimental group in people with Nutrition Disorders and Head and Neck Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Disorders, Head and Neck Cancer
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2019to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens
Dakpé Stéphanie, MD
About this study
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
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.
Read more
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.
- Conditions
- Nutrition Disorders, Head and Neck Cancer
- Being tested
- Experimental group
- Medical subject headings
- Nutrition Disorders, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called multidisciplinary specific consultation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
The score PG-SGA (index of Detsky)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Mar 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a pilot study to compare experimental group (improved coverage) and control group (classic coverage)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Dakpé, MD, Principal investigator, CHU Amiens Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632200
- Sponsor's protocol ID
- PI2018_843_0015
- Acronym
- NUTRIMAX
- Status last verified
- May 2026
- First submitted
- 16 Jul 2018
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03632200
- Acronym / sponsor ID
- NUTRIMAX / PI2018_843_0015
- Conditions
- Nutrition Disorders, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a pilot study to compare experimental group (improved coverage) and control group (classic coverage)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupThe 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. |
| Control group | No intervention | –The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: multidisciplinary specific consultationThe 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 |
Primary outcome
The satisfactory nutritional state defined by the absence of loss of weight
Time frame: 6 months
weight loss difference equal to 0 between the time 0 and the 6th month
1 secondary outcome
The score PG-SGA (index of Detsky)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie Dakpé, MD principal investigator
CHU Amiens Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Nutrition Disorders and Head and Neck Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Dakpé, MD (+330322089080, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The satisfactory nutritional state defined by the absence of loss of weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.