Evaluating a special nutritional drink for patients with gastrointestinal cancer undergoing surgery

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 study is testing whether a special nutritional drink can help patients with gastrointestinal cancer feel better during their recovery after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 14 sites (Beijing and 13 other locations)
• Trial ID: NCT05606848 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, open-label, active-controlled, multi-centre, non-inferiority study aimed at assessing the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer who are scheduled for surgical resection. A total of up to 350 patients will be randomly assigned to receive either the Fresubin Support Drink or an Enteral Nutrition Emulsion. The study will evaluate various health parameters, including prealbumin, albumin, C-reactive protein, vital signs, and adverse events, to determine the nutritional support's impact during the perioperative period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed gastrointestinal cancer scheduled for surgical resection and who meet specific health criteria.

Not a fit: Patients with contraindications to enteral nutrition or those requiring emergency surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve nutritional support and recovery outcomes for patients undergoing surgery for gastrointestinal cancer.

How similar studies have performed: Other studies have shown promise in using specialized nutritional support for cancer patients, but this specific approach is being evaluated for the first time.

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

Where this trial is running

Beijing and 13 other locations

• Beijing Hospital — Beijing, China (Recruiting)
• Beijing Cancer Hospital — Beijing, China (Recruiting)
• Capital Medical University Affiliated Beijing Shijitan Hospital — Beijing, China (Recruiting)
• Peking University People's Hospital — Beijing, China (Recruiting)
• Xiangya Hospital Central South University — Changsha, China (Recruiting)
• The First Affiliated Hospital Of Guangzhou Medical University — Guangzhou, China (Recruiting)
• Nanfang Hospital — Guanzhou, China (Recruiting)
• Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university） — Kunming, China (Recruiting)
• Jiangsu Province Hospital of Chinese Medicine — Nanjing, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
• The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital） — Shijia Zhuang, China (Recruiting)
• The First Affiliated Hospital of SOOCHOW University — Suzhou, China (Recruiting)
• The Central Hospital of Wuhan — Wuhan, China (Recruiting)
• Union hospital tongji medical college huazhong university of science and technology — Wuhan, China (Recruiting)

Study contacts

• Principal investigator: Hanping Shi, MD — Capital Medical University Affiliated Beijing Shijitan Hospital
• Study coordinator: Haiwei Li

Conditions Gastrointestinal Cancer