Clinical trial NCT06698783: Practical Application and Evaluation of Fortimel in Oncology Patients
Official title: Practical Application and Evaluation of Fortimel Taste Optimization Nutritional Support in Oncology Patients: a Multicenter Real-World Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: weight
timeFrame: One week before intervention and day 1, day 14 and day 28 of intervention.
measure: fat-free mass index
timeFrame: One week before intervention and day 1, day 7,day 14,day 21, and day 28 of intervention.
measure: skeletal muscle index
timeFrame: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
measure: food intake change
timeFrame: One week before intervention and day 1, day 7, day 14, day 21, and day 28 of intervention.
Secondary outcomes:
measure: Satiety
timeFrame: Day 1, day 14,and day 28 of intervention
measure: Gastrointestinal reactions
timeFrame: Day 1, day 14,and day 28 of intervention
measure: Adherence to nutritional formulations
timeFrame: Day 1, day 14,and day 28 of intervention
measure: 24h dietary intake
timeFrame: Day 1, day 14,and day 28 of intervention
Other outcomes:
measure: Major complications during treatment
timeFrame: 28 days since the intervention.
Locations:
city: Beijing
country: China
facility: Dongcheng district，Peking union medical college hospital
state: Beijing
Study officials:
References: