"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"

Medical University of Gdansk

Status: Unknown

Conditions: Gastric Cancer; Colorectal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04980950

MUG

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

gastric cancer patients (immunonutrition)

Experimental group

Description:

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

Treatment:

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

gastric cancer patients (standard nutrition)

Active Comparator group

Description:

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

Treatment:

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

colorectal cancer patients (immunonutrition)

Experimental group

Description:

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

Treatment:

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

colorectal cancer patients (standard nutrition)

Active Comparator group

Description:

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

Treatment:

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