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

Last updated: April 29, 2025
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasopharyngeal Cancer

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Treatment

Control Nutritional Support

Immunonutrition

Clinical Study ID

NCT04611113
20200060578
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of head-neck cancer

  • indication to curative or adjuvant chemoradiotherapy

  • availability to planned measurements and to written informed consent.

Exclusion

Exclusion Criteria:

  • age <18 years

  • indication to or ongoing artificial nutrition

  • refusal

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: Control Nutritional Support
Phase:
Study Start date:
March 17, 2021
Estimated Completion Date:
November 15, 2026

Study Description

In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level.

Connect with a study center

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

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