NCT04980950

Brief Summary

Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

April 21, 2021

Last Update Submit

July 29, 2021

Conditions

Gastric CancerColorectal Cancer

Keywords

gut microbiotagut barrier integrityenteral immunonutritiongastric cancercolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.

    The composition of gut microbiota (bacteria and fungi) will be assessed from stools. The amounts of bacteria/fungi will be presented using bioinformatics tools and there is no precisely described units (only the total number).

    at baseline and after 7 and 10 days

Secondary Outcomes (2)

  • The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.

    at baseline and after 7 and 10 days

  • The impact of immunonutrition on intestines in gastric and colorectal cancer patients.

    at baseline and after 7 and 10 days

Study Arms (4)

gastric cancer patients (immunonutrition)

EXPERIMENTAL

Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.

Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

gastric cancer patients (standard nutrition)

ACTIVE COMPARATOR

These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.

Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

colorectal cancer patients (immunonutrition)

EXPERIMENTAL

Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.

Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

colorectal cancer patients (standard nutrition)

ACTIVE COMPARATOR

These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.

Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

Interventions

Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health ScienceDIETARY_SUPPLEMENT

Gastric and colorectal cancer patients will receive 1 bottle of immunonutrition or standard nutrition for 10 days. The aims of this study is to assess the effects of these immunonutrition on gut microbiota, intestinal permeability as well as inflammation of intestines in gastric and colorectal cancer patients.

colorectal cancer patients (immunonutrition)colorectal cancer patients (standard nutrition)gastric cancer patients (immunonutrition)gastric cancer patients (standard nutrition)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 y.o.
  • patients with gastric or colorectal cancer
  • patients treated in Department of Surgical Oncology, Medical University of Gdańsk
  • patients' agreement to take part in this study

You may not qualify if:

  • age \<18 y.o.
  • other types of cancer than gastric/colorectal cancer
  • the presence of inflammatory bowel disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karolina Kaźmierczak-Siedlecka (nutritionist, PhD), senior assistant, Department of Surgical Oncology

Study Record Dates

First Submitted

April 21, 2021

First Posted

July 28, 2021

Study Start

August 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share