Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck (NUTRIMAX)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03632200 |
|
Recruitment Status :
Recruiting
First Posted : August 15, 2018
Last Update Posted : August 24, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nutrition Disorders Head and Neck Cancer | Other: Experimental group | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | a pilot study to compare experimental group (improved coverage) and control group (classic coverage) |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Actual Study Start Date : | March 21, 2019 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2021 |
| Arm | Intervention/treatment |
|---|---|
|
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
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 Name: multidisciplinary specific consultation |
|
No Intervention: Control group
The patients will be followed according to the current recommendations of the French Society Clinical Nutrition and Metabolism (SFNEP).
|
- 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
- The score PG-SGA (index of Detsky) [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632200
| Contact: Stéphanie Dakpé, MD | +330322089080 | dakpe.stephanie@chu-amiens.fr |
| France | |
| CHU Amiens-Picardie | Recruiting |
| Amiens, France | |
| Contact: Dakpé Stéphanie, MD | |
| Principal Investigator: | Stéphanie Dakpé, MD | CHU Amiens Picardie |
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT03632200 |
| Other Study ID Numbers: |
PI2018_843_0015 |
| First Posted: | August 15, 2018 Key Record Dates |
| Last Update Posted: | August 24, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Head and Neck Neoplasms Nutrition Disorders Neoplasms by Site Neoplasms |