- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665714
Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The present protocol describes a randomized, active-controlled, open labelled study in which either IMPACT Oral or Enteral Nutrition Emulsion(TPF-T) will be given to surgical patients for 5 days before surgery and 7 days after surgery. Both of the study products include immunonutrition, but the nutrient proportion is different.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Peiking Union Medical College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with upper or lower gastrointestinal cancer confirmed by histological method and scheduled for radical resection via open or laparoscopic surgery plus gastrointestinal reconstruction. Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening.
- Age18-75 years old (include 18 and 75 years old).
- Body Mass Index 18.5-28kg/m2 (include 18.5 and28kg/m2).
- Life expectancy more than 3 months.
- Plasma haemoglobin ≥ 90g/l.
- Plasma albumin ≥2.5 g/dl.
- No blood product infused within 1 week prior to screening.
- Patients are informed for consent, and agreed to participate in the study and sign the informed consent.
Exclusion Criteria:
- Severe concomitant clinical conditions that could jeopardize the trial performance and follow-up.
- Past history of gastrointestinal surgery or other treatment of digestive tract, and affect the nutrient absorption
- Female patient who is pregnant or lactating woman.
- Patient undergoing minor gastrointestinal cancer surgery such as confirmatory biopsy or endoscopy. Patient that has endoscopic tumour resection is also excluded.
- Patient is not allowed any oral or enteral intake in the pre-operative phase of the study.
- Having participated in another interventional clinical trial including those related to nutritional support within 4 weeks prior to the patient enrollment.
- Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
- Patient who is not willing and not able to comply with scheduled visits and the requirements of the study protocol.
- Planned chemotherapy, radiotherapy or immunotherapy during the first 7 days following the surgical tumour resection.
- 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).
- Known to have diabetes or fasting blood glucose≥ 10mmol/L.
- Known to have hyperthreosis or hypothyreosis
- Patient currently treated with Omega-3 fatty acid-containing fat emulsion, glutamine, thymosin, hormone, thyroxine, growth hormone, anti-TNF biological.
- Known to have allergic history to any component of the investigational product.
- Uncontrolled psychological disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Impact Oral
Preoperatively: 1 bottle each time (250ml/bottle), 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively:
|
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
TPF-T
Other Names:
|
Active Comparator: Enteral nutrition Emulsion(TPF-T)
Preoperatively: 272ml each time, 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively:
|
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
TPF-T
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Serum Prealbumin level
Time Frame: Change measures at baseline and Day 8 after surgery
|
The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment).
|
Change measures at baseline and Day 8 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Serum Prealbumin level
Time Frame: Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery
|
Prealbumin at baseline and Day -1 before the day of surgery, and Day1 and Day 3 after the day of surgery.
|
Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery
|
Change of Albumin
Time Frame: Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery)
|
Albumin at baseline, Day-1 before the day of surgery, and on Day 1, 3 and 8 after the day of surgery.
|
Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery)
|
Change of C-reactive protein
Time Frame: Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery)
|
C-reactive protein at baseline, Day -1 before the day of surgery, and on Day 1, 3,8 after the day of surgery.
|
Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery)
|
Change of Interleukin-6 (IL-6)
Time Frame: Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery)
|
Interleukin-6 (IL-6) at baseline, Day -1 before the day of surgery, and on Day1, 3 and 8 after the day of surgery
|
Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery)
|
Change of CD4+/CD8+
Time Frame: Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery)
|
CD4+/CD8+ at baseline, Day-1 before the day of surgery, and on Day1, 3, 8 after the day of surgery(selected sites)
|
Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery)
|
Incidence of postoperative Infections
Time Frame: up to Day 8 after surgery
|
Incidence of postoperative infections up to Day 8 after surgery
|
up to Day 8 after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jianchun Yu, MD, Peiking Union Medical College Hospital
- Principal Investigator: Gang Xiao, MD, Beijing Hospital
- Principal Investigator: Yingjiang Ye, MD, Peiking University People's Hospital
- Principal Investigator: Baogui Wang, MD, Tianjin tumor hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.01. CN. NHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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