AzTrials
AzTrials

Gastrointestinal CancerNCT03665714

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

A study testing Impact Oral and Enteral Nutrition Emulsion(TPF-T) in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
Impact Oral and Enteral Nutrition Emulsion(TPF-T)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
1 siteChina
Study dates
23 Oct 2018to 31 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peiking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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.

Read the 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.

Being tested
Impact Oral, Enteral Nutrition Emulsion(TPF-T)
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impact OralOther

    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)Other

    Also called Changnei Yingyang Ruji(TPF-T)

    TPF-T

Study groups in NCT03665714
Study groupRoleWhat they receive
Impact OralExperimentalPreoperatively: 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.
Receives: Other: Impact Oral; Other: Enteral Nutrition Emulsion(TPF-T)
Enteral nutrition Emulsion(TPF-T)Active comparatorPreoperatively: 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.
Receives: Other: Impact Oral; Other: Enteral Nutrition Emulsion(TPF-T)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Serum Prealbumin level

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

    Measured: Change measures at baseline and Day 8 after surgery

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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

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

  5. 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)

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

  6. Incidence of postoperative Infections

    Incidence of postoperative infections up to Day 8 after surgery

    Measured: up to Day 8 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start23 Oct 2018
  3. Primary completion21 Sep 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665714
Sponsor's protocol ID
17.01. CN. NHS
Status last verified
Sep 2020
First submitted
7 Sep 2018
Last updated
21 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Impact Oral and Enteral Nutrition Emulsion(TPF-T) in people with Gastrointestinal Cancer, run by Société des Produits Nestlé (SPN) at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Serum Prealbumin level (time frame: Change measures at baseline and Day 8 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in