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

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ClinicalTrials.gov Identifier: NCT03665714
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Other: Impact Oral Other: Enteral Nutrition Emulsion(TPF-T) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Impact Oral

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

Other: Enteral Nutrition Emulsion(TPF-T)
TPF-T
Other Name: Changnei Yingyang Ruji(TPF-T)

Active Comparator: Enteral nutrition Emulsion(TPF-T)

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

Other: Enteral Nutrition Emulsion(TPF-T)
TPF-T
Other Name: Changnei Yingyang Ruji(TPF-T)




Primary Outcome Measures :
  1. Change of Serum Prealbumin level [ Time Frame: 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 :
  1. Change of Serum Prealbumin level [ Time Frame: 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.

  2. Change of Albumin [ Time Frame: 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.

  3. Change of C-reactive protein [ Time Frame: 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.

  4. Change of Interleukin-6 (IL-6) [ Time Frame: 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

  5. Change of CD4+/CD8+ [ Time Frame: 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)

  6. Incidence of postoperative Infections [ Time Frame: up to Day 8 after surgery ]
    Incidence of postoperative infections up to Day 8 after surgery



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665714


Contacts
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Contact: Yaling Li 86 10 84348448 Jessie.li1@cn.nestle.com

Locations
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China, Beijing
Peiking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jianchun Yu, MD    8601069152210    yu-jch@163.com   
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: 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

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03665714     History of Changes
Other Study ID Numbers: 17.01. CN. NHS
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases