Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer

Not Applicable

Completed

• Conditions: Gastrointestinal Cancer

• Registration Number: NCT03665714
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Study Start: 2018-10-23
• Status Verified: 2020-09
• Primary Completion: 2020-09-21
• Study Completion: 2020-10-31
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Serum Prealbumin level	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).

Secondary Outcome Measures

Name	Time	Method
Change of Serum Prealbumin level	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 of Interleukin-6 (IL-6)	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 of CD4+/CD8+	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 of Albumin	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 of C-reactive protein	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.
Incidence of postoperative Infections	up to Day 8 after surgery	Incidence of postoperative infections up to Day 8 after surgery

Trial Locations

Locations (1)

Peiking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China