Clinical trial NCT03665714: Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Official title: Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral nutrition therapy, the other half will receive Enteral Nutrition Emulsion(TPF-T) therapy.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Severe concomitant clinical conditions that could jeopardize the trial performance and follow-up.
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.

Primary outcomes:
measure: Change of Serum Prealbumin level
timeFrame: Change measures at baseline and Day 8 after surgery
Secondary outcomes:
measure: Change of Serum Prealbumin level
timeFrame: Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery
measure: Change of Albumin
timeFrame: Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery)
measure: Change of C-reactive protein
timeFrame: Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery)
measure: Change of Interleukin-6 (IL-6)
timeFrame: Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery)
measure: Change of CD4+/CD8+
timeFrame: Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery)
measure: Incidence of postoperative Infections
timeFrame: up to Day 8 after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peiking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peiking Union Medical College Hospital
name: Jianchun Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Gang Xiao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peiking University People's Hospital
name: Yingjiang Ye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Tumor Hospital
name: Baogui Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: