Practical Application and Evaluation of Fortimel in Oncology Patients

Practical Application and Evaluation of Fortimel Taste Optimization Nutritional Support in Oncology Patients: a Multicenter Real-World Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: Fortimel

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Dongcheng district，Peking union medical college hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group

Dietary supplement: Fortimel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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.	28 days since the intervention.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: K6287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No