To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: Nutrition Emulsion (TPF-T); Other: Foods for special medical purposes [FSMP] for patients with tumors

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiwei Li; Phone Number: +86 10 56632760; Email: li.haiwei@sspc.com.cn

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Beijing Hospital
    • Contact: Qi An
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Bin Liang; Phone Number: 010-88326666
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Ziyu Li; Phone Number: 010-88121122
  • Beijing, China
    • Recruiting
    • Capital Medical University Affiliated Beijing Shijitan Hospital
    • Contact: Hanping Shi, Doctor; Phone Number: 010-63925588
    • Principal Investigator: Hanping Shi, Doctor
  • Changsha, China
    • Recruiting
    • Xiangya Hospital Central South University
    • Contact: Zhikang Chen; Phone Number: 0731-89753999
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
    • Contact: Jiongqiang Huang; Phone Number: (8620) 83062114
  • Guanzhou, China
    • Recruiting
    • Nanfang Hospital
    • Contact: Qing Li
    • Contact: Jiang Yu; Phone Number: 020-61641888
  • Kunming, China
    • Recruiting
    • Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）
    • Contact: Youguo Dai; Phone Number: 0871-68185656
  • Nanjing, China
    • Recruiting
    • Jiangsu Province Hospital of Chinese Medicine
    • Contact: Zhiwei Jiang; Phone Number: 025-86617141
  • Qingdao, China
    • Recruiting
    • The Affiliated Hospital of Qingdao University
    • Contact: Yanbing Zhou; Phone Number: 0532-96166
  • Shijia Zhuang, China
    • Recruiting
    • The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
    • Contact: Yong Li; Phone Number: 0311 - 86095588
  • Suzhou, China
    • Recruiting
    • The First Affiliated Hospital of Soochow University
    • Contact: Lei Qin; Phone Number: 0512-65223637
    • Contact: Li Zhou
  • Wuhan, China
    • Recruiting
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Contact: Kaixiong Tao; Phone Number: 027-85726114
  • Wuhan, China
    • Recruiting
    • The Central Hospital of Wuhan
    • Contact: Hui Wang; Phone Number: 027-82811080

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control product; Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy	Other: Nutrition Emulsion (TPF-T); All patients will be randomized to receive the FSMP or control product.; Before the surgery: Patients daily intake control product with recommended energy.; 1-8 days after surgery: Patients gradually increase control product intake to reach the recommended energy.
Experimental: Study prodcut; Foods for special medical purposes [FSMP] for patients with tumors	Other: Foods for special medical purposes [FSMP] for patients with tumors; All patients will be randomized to receive the FSMP or control product.; Before the surgery: Patients daily intake FSMP with recommended energy.; 1-8 days after surgery: Patients gradually increase FSMP intake to reach the recommended energy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in serum prealbumin	from baseline to close out visit (Post-operation Day 5-8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum prealbumin		from baseline to Visit 2（Pre-operation Day 1）, Visit 3（Post-operation Day 1） and Visit 4（Post-operation Day 5 or 6）
Change in body weight (%)		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)
Change in serum albumin		from baseline to Visit 3（Post-operation Day 1） and close out visit(Post-operation Day 5-8)
Change in BMI	weight in kilograms, height in meters，weight and height will be combined to report BMI in kg/m^2	from baseline to close out visit(Post-operation Day 5-8)
Change in PG-SGA		from baseline to Close out Visit(Post-operation Day 5-8)
Change in grip strength	hand grip strength measured in kg	from baseline to Close out Visit(Post-operation Day 5-8)
Change in CRP		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in total lymphocyte count		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in total number of CD4+and CD8+		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in CD4+ % and CD8+%	the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes	from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in CD4+ T lymphocytes /CD8+ T lymphocytes		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in neutrophil/lymphocyte ratio		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in blood glucose		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in lipids		from baseline to Visit 3（Post-operation Day 1） and Close out Visit(Post-operation Day 5-8)
Change in ECOG performance status		from baseline to Close out Visit(Post-operation Day 5-8)
All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability		from baseline to Close out Visit(Post-operation Day 5-8)
Energy intake in kcal / kg BW	Total volume of IMP consumed	from baseline to Close out Visit(Post-operation Day 5-8)

Collaborators and Investigators

• Sponsor: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
• Investigators: Principal Investigator: Hanping Shi, MD, Capital Medical University Affiliated Beijing Shijitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: SUPE-001-CEN

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