Trial Title:
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
NCT ID:
NCT05606848
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nutrition Emulsion (TPF-T)
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.
Arm group label:
Control product
Intervention type:
Other
Intervention name:
Foods for special medical purposes [FSMP] for patients with tumors
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.
Arm group label:
Study prodcut
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Qi An
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Ziyu Li
Phone:
010-88121122
Facility:
Name:
Capital Medical University Affiliated Beijing Shijitan Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanping Shi, Doctor
Phone:
010-63925588
Investigator:
Last name:
Hanping Shi, Doctor
Email:
Principal Investigator
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Liang
Phone:
010-88326666
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhikang Chen
Phone:
0731-89753999
Facility:
Name:
The First Affiliated Hospital Of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiongqiang Huang
Phone:
(8620) 83062114
Facility:
Name:
Nanfang Hospital
Address:
City:
Guanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Yu
Phone:
020-61641888
Contact backup:
Last name:
Qing Li
Facility:
Name:
Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Youguo Dai
Phone:
0871-68185656
Facility:
Name:
Jiangsu Province Hospital of Chinese Medicine
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiwei Jiang
Phone:
025-86617141
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanbing Zhou
Phone:
0532-96166
Facility:
Name:
The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital）
Address:
City:
Shijia Zhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Li
Phone:
0311 - 86095588
Facility:
Name:
The First Affiliated Hospital of SOOCHOW University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Qin
Phone:
0512-65223637
Contact backup:
Last name:
Li Zhou
Facility:
Name:
The Central Hospital of Wuhan
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang
Phone:
027-82811080
Facility:
Name:
Union hospital tongji medical college huazhong university of science and technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaixiong Tao
Phone:
027-85726114
Start date:
November 30, 2022
Completion date:
March 2025
Lead sponsor:
Agency:
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Agency class:
Industry
Source:
Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05606848
