Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
NCT ID: NCT03665714
Last Updated: 2020-12-21
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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COMPLETED
NA
308 participants
INTERVENTIONAL
2018-10-23
2020-10-31
Brief Summary
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Detailed Description
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Prealbumin, C-reaction protein (CRP), Albumin，immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters and the number, severity, seriousness, relatedness and outcome of Adverse Events (AEs) will be evaluated in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Impact Oral
Preoperatively:
1 bottle each time (250ml/bottle), 3 times per day, equivalent to approximately 1060.5kcal per day.
Postoperatively:
1. Patient should receive:
* 1 bottle (250 ml each) per day of test product on D 1 and D 2 post surgery, corresponding to 353.5Kcal.
* 2 bottles (250 ml each) per day of test product on D 3 and D 4 post surgery, corresponding to 707Kcal.
* 3 bottles (250 ml each) per day of test product on D 5, D 6 and D 7 post surgery, corresponding to 1060.5 kcal.
2. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal.
Impact Oral
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
Enteral Nutrition Emulsion(TPF-T)
TPF-T
Enteral nutrition Emulsion(TPF-T)
Preoperatively:
272ml each time, 3 times per day, equivalent to approximately 1060.5kcal per day.
Postoperatively:
1. Patient should receive:
* 272ml of control product on D 1 and D 2 post surgery, corresponding to 353.5Kcal.
* 544ml of control product on D 3 and D 4 post surgery, corresponding to 707Kcal.
* 816ml of control product on D 5, D 6 and D 7 post surgery, corresponding to 1060.5 kcal.
2. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal.
Impact Oral
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
Enteral Nutrition Emulsion(TPF-T)
TPF-T
Interventions
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Impact Oral
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
Enteral Nutrition Emulsion(TPF-T)
TPF-T
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age18-75 years old (include 18 and 75 years old).
3. Body Mass Index 18.5-28kg/m2 (include 18.5 and28kg/m2).
4. Life expectancy more than 3 months.
5. Plasma haemoglobin ≥ 90g/l.
6. Plasma albumin ≥2.5 g/dl.
7. No blood product infused within 1 week prior to screening.
8. Patients are informed for consent, and agreed to participate in the study and sign the informed consent.
Exclusion Criteria
2. Past history of gastrointestinal surgery or other treatment of digestive tract, and affect the nutrient absorption
3. Female patient who is pregnant or lactating woman.
4. Patient undergoing minor gastrointestinal cancer surgery such as confirmatory biopsy or endoscopy. Patient that has endoscopic tumour resection is also excluded.
5. Patient is not allowed any oral or enteral intake in the pre-operative phase of the study.
6. Having participated in another interventional clinical trial including those related to nutritional support within 4 weeks prior to the patient enrollment.
7. Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
8. Patient who is not willing and not able to comply with scheduled visits and the requirements of the study protocol.
9. Planned chemotherapy, radiotherapy or immunotherapy during the first 7 days following the surgical tumour resection.
10. Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal).
11. Known to have diabetes or fasting blood glucose≥ 10mmol/L.
12. Known to have hyperthreosis or hypothyreosis
13. Patient currently treated with Omega-3 fatty acid-containing fat emulsion, glutamine, thymosin, hormone, thyroxine, growth hormone, anti-TNF biological.
14. Known to have allergic history to any component of the investigational product.
15. Uncontrolled psychological disease.
18 Years
75 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jianchun Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Peiking Union Medical College Hospital
Gang Xiao, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Yingjiang Ye, MD
Role: PRINCIPAL_INVESTIGATOR
Peiking University People's Hospital
Baogui Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Tumor Hospital
Locations
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Peiking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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17.01. CN. NHS
Identifier Type: -
Identifier Source: org_study_id