To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
NCT ID: NCT05606848
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2022-11-30
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control product
Nutrition Emulsion (TPF-T) is a tumor-specific enteral nutrition therapy
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.
Study prodcut
Foods for special medical purposes \[FSMP\] for patients with tumors
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Hanping Shi, MD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University Affiliated Beijing Shijitan Hospital
Locations
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Beijing Hospital
Beijing, , China
Beijing Cancer 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, , China
Countries
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Central Contacts
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Facility Contacts
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Qi An
Role: primary
Ziyu Li
Role: primary
Hanping Shi, Doctor
Role: primary
Bin Liang
Role: primary
Zhikang Chen
Role: primary
Jiongqiang Huang
Role: primary
Jiang Yu
Role: primary
Qing Li
Role: backup
Youguo Dai
Role: primary
Zhiwei Jiang
Role: primary
Yanbing Zhou
Role: primary
Yong Li
Role: primary
Lei Qin
Role: primary
Li Zhou
Role: backup
Hui Wang
Role: primary
Kaixiong Tao
Role: primary
Other Identifiers
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SUPE-001-CEN
Identifier Type: -
Identifier Source: org_study_id
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