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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665714
• Other study ID #: 17.01. CN. NHS
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: September 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: October 31, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
China	Peiking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Serum Prealbumin level	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	Change of Serum Prealbumin level	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
Secondary	Change of Albumin	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)
Secondary	Change of C-reactive protein	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)
Secondary	Change of Interleukin-6 (IL-6)	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)
Secondary	Change of CD4+/CD8+	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)
Secondary	Incidence of postoperative Infections	Incidence of postoperative infections up to Day 8 after surgery	up to Day 8 after surgery