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

Primary Purpose

Gastrointestinal Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutrition Emulsion (TPF-T)
Foods for special medical purposes [FSMP] for patients with tumors
Sponsored by
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Agreed to participate in the study with signed ICF; Age 18-75 years; Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery; Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening; Hemoglobin ≥ 90 g/L Albumin ≥ 2.5 g/dL BMI ≥18.5 and ≤29 kg/m2; ECOG Performance status 0-2 preoperatively; Life expectancy >6 months. Exclusion criteria Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0); Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia; Conditions requiring emergency surgery; 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; Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis); Cardiac dysfunction (New York Heart Association Functional Class > III); Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN; Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis; Active treatment refractory bleeding; Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours); Known disease that could seriously affect the digestion and absorption of the IMPs; History of drug or alcohol abuse within 6 months prior to screening; 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; Current use of muscle growth supporting substances (e.g., anabolics) at screening; Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection; Transfusion of blood products within 1 week before screening; Known allergy to contents of the study product or control product; Pregnancy or lactation; 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; 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; Considered not suitable for study participation by the investigator

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control product

Study prodcut

Arm Description

Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy

Foods for special medical purposes [FSMP] for patients with tumors

Outcomes

Primary Outcome Measures

Change in serum prealbumin

Secondary Outcome Measures

Change in body weight (%)
Change in serum prealbumin
Change in serum albumin
Change in BMI
weight in kilograms, height in meters,weight and height will be combined to report BMI in kg/m^2
Change in PG-SGA
Change in grip strength
hand grip strength measured in kg
Change in CRP
Change in total lymphocyte count
Change in total number of CD4+and CD8+
Change in CD4+ % and CD8+%
the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes
Change in CD4+ T lymphocytes /CD8+ T lymphocytes
Change in neutrophil/lymphocyte ratio
Change in blood glucose
Change in lipids
Change in ECOG performance status
All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability
Energy intake in kcal / kg BW
Total volume of IMP consumed

Full Information

First Posted
October 27, 2022
Last Updated
January 18, 2023
Sponsor
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05606848
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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) . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control product
Arm Type
Active Comparator
Arm Description
Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy
Arm Title
Study prodcut
Arm Type
Experimental
Arm Description
Foods for special medical purposes [FSMP] for patients with tumors
Intervention Type
Other
Intervention Name(s)
Nutrition Emulsion (TPF-T)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Foods for special medical purposes [FSMP] for patients with tumors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum prealbumin
Time Frame
from baseline to close out visit(Post-operation Day 8)
Secondary Outcome Measure Information:
Title
Change in body weight (%)
Time Frame
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)
Title
Change in serum prealbumin
Time Frame
from baseline to Visit 2(Pre-operation Day 1), Visit 3(Post-operation Day 1) and Visit 4(Post-operation Day 5 or 6)
Title
Change in serum albumin
Time Frame
from baseline to Visit 3(Post-operation Day 1) and close out visit(Post-operation Day 8)
Title
Change in BMI
Description
weight in kilograms, height in meters,weight and height will be combined to report BMI in kg/m^2
Time Frame
from baseline to close out visit(Post-operation Day 8)
Title
Change in PG-SGA
Time Frame
from baseline to Close out Visit(Post-operation Day 8)
Title
Change in grip strength
Description
hand grip strength measured in kg
Time Frame
from baseline to Close out Visit(Post-operation Day 8)
Title
Change in CRP
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in total lymphocyte count
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in total number of CD4+and CD8+
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in CD4+ % and CD8+%
Description
the respective percentage of CD4+ T lymphocytes and CD8+ T lymphocytes in total lymphocytes
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in CD4+ T lymphocytes /CD8+ T lymphocytes
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in neutrophil/lymphocyte ratio
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in blood glucose
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in lipids
Time Frame
from baseline to Visit 3(Post-operation Day 1) and Close out Visit(Post-operation Day 8)
Title
Change in ECOG performance status
Time Frame
from baseline to Close out Visit(Post-operation Day 8)
Title
All adverse events (AEs), including serious adverse events (SAEs) for assessment of safety and tolerability
Time Frame
from baseline to Close out Visit(Post-operation Day 8)
Title
Energy intake in kcal / kg BW
Description
Total volume of IMP consumed
Time Frame
from baseline to Close out Visit(Post-operation Day 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Agreed to participate in the study with signed ICF; Age 18-75 years; Patient has gastrointestinal cancer confirmed by histological or imagological method and scheduled for resection via open or laparoscopic surgery; Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening; Hemoglobin ≥ 90 g/L Albumin ≥ 2.5 g/dL BMI ≥18.5 and ≤29 kg/m2; ECOG Performance status 0-2 preoperatively; Life expectancy >6 months. Exclusion criteria Contraindication or intolerance against EN, e.g., acute gastrointestinal bleeding, ileus (Grade≥3 NCI-CTCAE v 5.0); Any congenital defect of amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosaemia; Conditions requiring emergency surgery; 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; Known treatment refractory metabolic disease (e.g., poorly-controlled diabetes mellitus or fasting blood glucose≥ 10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis); Cardiac dysfunction (New York Heart Association Functional Class > III); Severe hepatic dysfunction associated with significant increase of AST or ALT > 5 ULN or bilirubin > 3 ULN; Severe renal dysfunction associated with serum creatinine concentration > 1.5 ULN and/or required dialysis; Active treatment refractory bleeding; Other malignancies in the last 3 years (except for successfully treated in situ basocellular skin or in situ cervical uterine tumours); Known disease that could seriously affect the digestion and absorption of the IMPs; History of drug or alcohol abuse within 6 months prior to screening; 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; Current use of muscle growth supporting substances (e.g., anabolics) at screening; Planned chemotherapy, radiotherapy or immunotherapy during the first 12 days following the surgical tumor resection; Transfusion of blood products within 1 week before screening; Known allergy to contents of the study product or control product; Pregnancy or lactation; 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; 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; Considered not suitable for study participation by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanping Shi, MD
Organizational Affiliation
Capital Medical University Affiliated Beijing Shijitan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Capital Medical University Affiliated Beijing Shijitan Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Facility Name
The First Affiliated Hospital Of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
Nanfang Hospital
City
Guanzhou
Country
China
Facility Name
Yunnan Cancer Hospital(The affiliated hospital of Kunming medical university)
City
Kunming
Country
China
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
City
Shijia Zhuang
Country
China
Facility Name
The First Affiliated Hospital of SOOCHOW University
City
Suzhou
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
Country
China
Facility Name
Union hospital tongji medical college huazhong university of science and technology
City
Wuhan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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