Clinical trial NCT05606848: To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
Official title: Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.

Detailed description: This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . Not exceed 350 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1.

Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study.

Eligibility criteria: Inclusion criteria

1. Agreed to participate in the study with signed ICF;
2. Age 18-75 years;
3. Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery;
4. Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening;
5. Hemoglobin ≥ 90 g/L
6. Albumin ≥ 2.5 g/dL
7. BMI ≥18.5 and ≤29 kg/m2;
8. ECOG Performance status 0-2 preoperatively;
9. Expected survival time \>6 months.

Exclusion criteria

1. Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0);
2. Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia;
3. Conditions requiring emergency surgery;
4. Conditions other than cancer and surgery that can be associated with loss of body weight e.g. serious active clinical infections (\> Grade 2, NCI-CTCAE 5.0), including active tuberculosis, or self-reported HIV infection or active hepatitis B or C;
5. Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis);
6. Cardiac dysfunction (New York Heart Association Functional Class \> III);
7. Severe hepatic dysfunction associated with significant increase of AST or ALT \> 5 ULN or bilirubin \> 3 ULN;
8. Severe renal dysfunction associated with serum creatinine concentration \> 1.5 ULN and/or required dialysis;
9. Active treatment refractory bleeding;
10. Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours);
11. Known disease that could seriously affect the digestion and absorption of the IMPs;
12. History of drug or alcohol abuse within 6 months prior to screening;
13. Current use of medication or nutritional supplements containing more than 500 mg of EPA+DHA/day or fish oil capsules/ supplements containing more than 500 mg EPA + DHA/day at screening;
14. Current use of muscle growth supporting substances (e.g., anabolics) at screening;
15. Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection;
16. Transfusion of blood products within 1 week before screening;
17. Known allergy to contents of the study product or control product;
18. Pregnancy or lactation;
19. Participation in another clinical study with an investigational drug, FSMP or an investigational medical device one month prior to start of study or planned participation in another clinical trial as specified before during the course of the study period;
20. Patient who is unable to understand the spoken and written information or not willing or not able to comply with scheduled visits and the requirements of the study protocol;
21. Considered not suitable for study participation by the investigator

Primary outcomes:
measure: Change in serum prealbumin
timeFrame: from baseline to close out visit (Post-operation Day 5-8)
Secondary outcomes:
measure: Change in body weight (%)
timeFrame: from baseline to Visit 2（Pre-operation Day 1）, Visit 4（Post-operation Day 5 or 6） and close out visit(Post-operation Day 5-8)
measure: Change in serum prealbumin
timeFrame: from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1） and Visit 4（Post-operation Day 5 or 6）
measure: Change in serum albumin
timeFrame: from baseline to Visit 3（Post-operation Day 1） and close out visit(Post-operation Day 5-8)
measure: Change in BMI
timeFrame: from baseline to close out visit(Post-operation Day 5-8)
measure: Change in PG-SGA
timeFrame: from baseline to Close out Visit(Post-operation Day 5-8)
measure: Change in grip strength
timeFrame: from baseline to Close out Visit(Post-operation Day 5-8)
measure: Change in CRP
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in total lymphocyte count
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in total number of CD4+and CD8+
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in CD4+ % and CD8+%
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in CD4+ T lymphocytes /CD8+ T lymphocytes
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in neutrophil/lymphocyte ratio
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in blood glucose
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in lipids
timeFrame: from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
measure: Change in ECOG performance status
timeFrame: from baseline to Close out Visit(Post-operation Day 5-8)
measure: All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability
timeFrame: from baseline to Close out Visit(Post-operation Day 5-8)
measure: Energy intake in kcal / kg BW
timeFrame: from baseline to Close out Visit(Post-operation Day 5-8)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Shijitan Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
city: Guanzhou
country: China
facility: Nanfang Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital）
city: Suzhou
country: China
facility: The First Affiliated Hospital of SOOCHOW University
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Union hospital tongji medical college huazhong university of science and technology
Study officials:
affiliation: Capital Medical University Affiliated Beijing Shijitan Hospital
name: Hanping Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: