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

Primary Purpose

Gastrointestinal Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Impact Oral

Enteral Nutrition Emulsion(TPF-T)

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Peiking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Impact Oral

Enteral nutrition Emulsion(TPF-T)

Arm Description

Preoperatively: 1 bottle each time (250ml/bottle), 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively: 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. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal.

Preoperatively: 272ml each time, 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively: 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. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal.

Outcomes

Primary Outcome Measures

Change of Serum Prealbumin level

The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment).

Secondary Outcome Measures

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 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 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 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 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)

Incidence of postoperative Infections

Incidence of postoperative infections up to Day 8 after surgery

Full Information

NCT ID

NCT03665714

First Posted

September 7, 2018

Last Updated

December 18, 2020

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT03665714

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 23, 2018 (Actual)

Primary Completion Date

September 21, 2020 (Actual)

Study Completion Date

October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

308 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Impact Oral

Arm Type

Experimental

Arm Description

Arm Title

Enteral nutrition Emulsion(TPF-T)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Impact Oral

Intervention Description

Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.

Intervention Type

Other

Intervention Name(s)

Enteral Nutrition Emulsion(TPF-T)

Other Intervention Name(s)

Changnei Yingyang Ruji(TPF-T)

Intervention Description

TPF-T

Primary Outcome Measure Information:

Title

Change of Serum Prealbumin level

Description

The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment).

Time Frame

Change measures at baseline and Day 8 after surgery

Secondary Outcome Measure Information:

Title

Change of Serum Prealbumin level

Description

Prealbumin at baseline and Day -1 before the day of surgery, and Day1 and Day 3 after the day of surgery.

Time Frame

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

Title

Change of Albumin

Description

Albumin at baseline, Day-1 before the day of surgery, and on Day 1, 3 and 8 after the day of surgery.

Time Frame

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

Title

Change of C-reactive protein

Description

C-reactive protein at baseline, Day -1 before the day of surgery, and on Day 1, 3,8 after the day of surgery.

Time Frame

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

Title

Change of Interleukin-6 (IL-6)

Description

Interleukin-6 (IL-6) at baseline, Day -1 before the day of surgery, and on Day1, 3 and 8 after the day of surgery

Time Frame

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

Title

Change of CD4+/CD8+

Description

CD4+/CD8+ at baseline, Day-1 before the day of surgery, and on Day1, 3, 8 after the day of surgery(selected sites)

Time Frame

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

Title

Incidence of postoperative Infections

Description

Incidence of postoperative infections up to Day 8 after surgery

Time Frame

up to Day 8 after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianchun Yu, MD

Organizational Affiliation

Peiking Union Medical College Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gang Xiao, MD

Organizational Affiliation

Beijing Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yingjiang Ye, MD

Organizational Affiliation

Peiking University People's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Baogui Wang, MD

Organizational Affiliation

Tianjin Tumor Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peiking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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