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

Gastrointestinal Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05606848
• Other study ID #: SUPE-001-CEN
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) . 250 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. Life expectancy >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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum prealbumin		from baseline to close out visit(Post-operation Day 8)
Secondary	Change in body weight (%)		from baseline to Visit 2(Pre-operation Day 1), Visit 3(Post-operation Day 1),Visit 4(Post-operation Day 5 or 6) and close out visit(Post-operation Day 8)
Secondary	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)
Secondary	Change in serum albumin		from baseline to Visit 3(Post-operation Day 1) and close out visit(Post-operation Day 8)
Secondary	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 8)
Secondary	Change in PG-SGA		from baseline to Close out Visit(Post-operation Day 8)
Secondary	Change in grip strength	hand grip strength measured in kg	from baseline to Close out Visit(Post-operation Day 8)
Secondary	Change in CRP		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in total lymphocyte count		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in total number of CD4+and CD8+		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	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 8)
Secondary	Change in CD4+ T lymphocytes /CD8+ T lymphocytes		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in neutrophil/lymphocyte ratio		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in blood glucose		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in lipids		from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Secondary	Change in ECOG performance status		from baseline to Close out Visit(Post-operation Day 8)
Secondary	All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability		from baseline to Close out Visit(Post-operation Day 8)
Secondary	Energy intake in kcal / kg BW	Total volume of IMP consumed	from baseline to Close out Visit(Post-operation Day 8)