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NCT Number: NCT06698783

Practical Application and Evaluation of Fortimel in Oncology Patients

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongcheng district，Peking union medical college hospital

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. weight

    Time frame: One week before intervention and day 1, day 14 and day 28 of intervention.

    weight measured by body composition analyzer

  2. fat-free mass index

    Time frame: 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

  3. skeletal muscle index

    Time frame: 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

  4. food intake change

    Time frame: 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 outcomes

  1. Satiety

    Time frame: Day 1, day 14,and day 28 of intervention

    VAS score

  2. Gastrointestinal reactions

    Time frame: Day 1, day 14,and day 28 of intervention

    enteral nutrition tolerance scale tool

  3. Adherence to nutritional formulations

    Time frame: Day 1, day 14,and day 28 of intervention

    using the patient's ONS compliance register

  4. 24h dietary intake

    Time frame: Day 1, day 14,and day 28 of intervention

Other outcomes

  1. Major complications during treatment

    Time frame: 28 days since the intervention.

    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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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