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

NCT03665714 | Completed

• 1 other identifier: 17.01. CN. NHS
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of Serum Prealbumin level

  Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery

• Change of Albumin

  Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery)

• Change of C-reactive protein

  Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery)

• Change of Interleukin-6 (IL-6)

  Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery)

• Change of CD4+/CD8+

  Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery)

Study Arms (2)

Impact Oral

EXPERIMENTAL

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.

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

Enteral nutrition Emulsion(TPF-T)

ACTIVE COMPARATOR

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.

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

Interventions

Impact Oral OTHER

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); Impact Oral

Enteral Nutrition Emulsion(TPF-T) OTHER

TPF-T

Also known as: Changnei Yingyang Ruji(TPF-T)

Enteral nutrition Emulsion(TPF-T); Impact Oral

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Peiking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: October 23, 2018
• Primary Completion: September 21, 2020
• Study Completion: October 31, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)