Practical Application and Evaluation of Fortimel in Oncology Patients

NCT06698783 | Not Yet Recruiting

• 1 other identifier: K6287
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Satiety

  Day 1, day 14,and day 28 of intervention

• Gastrointestinal reactions

  Day 1, day 14,and day 28 of intervention

• Adherence to nutritional formulations

  Day 1, day 14,and day 28 of intervention

• 24h dietary intake

  Day 1, day 14,and day 28 of intervention

Other Outcomes (1)

• Major complications during treatment

  28 days since the intervention.

Study Arms (1)

Intervention group

EXPERIMENTAL

Dietary Supplement: Fortimel

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Dongcheng district，Peking union medical college hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)