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This study is a multicenter registry and is a prospective, observational, real-world study.
Subjects were selected by clinicians for oral ONS nutritional intervention according to the actual clinical situation and the patient's wishes, and the observation period was 4 weeks.
Subjects will receive a ready-to-drink marketed formula for special medical purposes with 4 flavors for free Food liquid preparation (Nengli Yijia, Nutricia in the Netherlands) for rounds of nutritional intervention, providing
1 flavor per week, 1-2 bottles per day, 4 flavors for a total of 28 days. The basic nutritional status and quality of life of patients were mainly evaluated at multiple time nodes before and after nutritional intervention.
In order to improve the compliance of subjects, the all-round guardian platform (hereinafter referred to as the platform) by the China Initial Insurance Foundation was used during the intervention period to provide basic nutrition supervision, education and dietary guidance in routine nutrition support.
Recruitment method: Convenient sampling method is adopted, from the beginning of recruitment to the target sample size.
Follow-up period: After the start of the intervention, it will be carried out according to the plan of the follow-up task to the end of the intervention on the 28th day. The last telephone follow-up visit will complete on the 60th day after the end of the pre-end.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortimel | Dietary Supplement | In this study, patients will be provided with ONS preparation (4 kinds of ready-to-drink special medical food) free of charge during the treatment period. Doctors will provide patients with different flavor nutritional preparations on a weekly basis, 2 bottles per day for patients with 1 flavor per week, and 14 bottles per day for each of 4 flavors at the recommended dosage of 400 kcal per day 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight measured by body composition analyzer | One week before intervention and day 1, day 14 and day 28 of intervention. |
| fat-free mass index | fat-free mass index measured by body composition analyzer | One week before intervention and day 1, day 7,day 14,day 21, and day 28 of intervention. |
| skeletal muscle index | skeletal muscle index measured by body composition analyzer | One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention. |
| food intake change | calculated from recorded food intake through an online tool | One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety | VAS score | Day 1, day 14,and day 28 of intervention |
| Gastrointestinal reactions | enteral nutrition tolerance scale tool | Day 1, day 14,and day 28 of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Major complications during treatment | General adverse reactions (dizziness, headache, fatigue and weakness, loss of appetite, nausea and vomiting, hair loss, dry mouth, dyspepsia, stomach discomfort, tissue edema, constipation, diarrhea, blood in the stool, etc.), nosocomial infection, respiratory failure, cardiovascular events (stroke, intracranial hemorrhage, cardiac arrest, myocardial infarction, etc.), radiation brain reactions, radiation pulmonary fibrosis, radiation pneumonitis, radiation pharyngitis, radiation esophagitis, radiation xerostomia, radiation otitis media, radiation mandibular arthritis, radiation neck skin atrophy, radiation caries, hearing loss, deafness, bone marrow suppression, endocrine disorders, pulmonary embolism, myocarditis, enteritis, acute pancreatitis, acute renal failure, gastrointestinal events (bleeding, intestinal perforation, acute pancreatitis, etc.) or a decrease of 10% or more from baseline by the Barthel index. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongcheng district,Peking union medical college hospital | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Adherence to nutritional formulations | using the patient's ONS compliance register | Day 1, day 14,and day 28 of intervention |
| 24h dietary intake | Day 1, day 14,and day 28 of intervention |
| 28 days since the intervention. |