RecruitingNot ApplicableNCT04611113

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

Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer


Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

86 participants

Start Date

Mar 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • diagnosis of head-neck cancer
  • indication to curative or adjuvant chemoradiotherapy
  • availability to planned measurements and to written informed consent.

Exclusion Criteria3

  • age \<18 years
  • indication to or ongoing artificial nutrition
  • refusal

Interventions

DIETARY_SUPPLEMENTImmunonutrition

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_SUPPLEMENTControl 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.


Locations(1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

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NCT04611113


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