Practical Application and Evaluation of Fortimel in Oncology Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Not yet enrolling

Conditions

Cancer

Treatments

Dietary Supplement: Fortimel

Study type

Interventional

Funder types

Other

Identifiers

NCT06698783

K6287

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients signed informed consent and volunteered to participate in the study
Patients diagnosed with colorectal cancer or primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring, undifferentiated adenocarcinoma) or NSCLC stage I-iv. by histopathological examination of primary biopsy
Cancer patients who were receiving chemoradiotherapy or immunotherapy were given 2 points for nutritional risk screening, and patients who met the conditions of ONS nutrition intervention were voluntarily enrolled to receive ONS nutrition intervention with Nertronecar
Basic reading and communication skills
The expected survival time is greater than 6 months

Exclusion criteria

Combined cognitive dysfunction, mental disorder, impaired consciousness or unwillingness to partner
Contraindications with chemotherapy or immunotherapy
Prolonged bed rest, hemiplegia, or coma
Intolerance of allergies to nutrients or their main components, such as lactose or galactose
In the case of severe gastrointestinal symptoms of liver and kidney dysfunction, the serum creatinine glutamic pyruvic transaminase glutamic oxalacetic transaminase increases by more than 2.5 times, and the fasting blood glucose is over10mmol