Practical Application and Evaluation of Fortimel in Oncology Patients

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06698783
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2024-12-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
weight	One week before intervention and day 1, day 14 and day 28 of intervention.	weight measured by body composition analyzer
fat-free mass index	One week before intervention and day 1, day 7,day 14,day 21, and day 28 of intervention.	fat-free mass index measured by body composition analyzer
skeletal muscle index	One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.	skeletal muscle index measured by body composition analyzer
food intake change	One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.	calculated from recorded food intake through an online tool

Secondary Outcome Measures

Name	Time	Method
Satiety	Day 1, day 14,and day 28 of intervention	VAS score
Gastrointestinal reactions	Day 1, day 14,and day 28 of intervention	enteral nutrition tolerance scale tool
Adherence to nutritional formulations	Day 1, day 14,and day 28 of intervention	using the patient's ONS compliance register
24h dietary intake	Day 1, day 14,and day 28 of intervention

Trial Locations

Locations (1)

Dongcheng district，Peking union medical college hospital; 🇨🇳 Beijing, Beijing, China