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

Nestlé

Status: Completed

Conditions: Gastrointestinal Cancer

Treatments: Other: Impact Oral; Other: Enteral Nutrition Emulsion(TPF-T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03665714

17.01. CN. NHS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Impact Oral

Experimental group

Description:

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.

Treatment:

Other: Enteral Nutrition Emulsion(TPF-T)

Other: Impact Oral

Enteral nutrition Emulsion(TPF-T)

Active Comparator group

Description:

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.

Treatment:

Other: Enteral Nutrition Emulsion(TPF-T)

Other: Impact Oral