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Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

NCT04611113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-05-01

No results posted yet for this study

Summary

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck

Conditions

Interventions

DIETARY_SUPPLEMENT

Immunonutrition

In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

DIETARY_SUPPLEMENT

Control Nutritional Support

In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Riccardo Caccialanza, MD · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2026-11-15
Completion
2026-11-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04611113 on ClinicalTrials.gov