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

Head and Neck Cancer

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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether giving patients special nutrition supplements (immunonutrition) before and during combined chemotherapy and radiation can help them tolerate treatment better and experience fewer side effects, in people being treated for head and neck cancer. **You may be eligible if...** - You have been diagnosed with head or neck cancer - You are scheduled to receive chemotherapy combined with radiation therapy as part of curative or follow-up (adjuvant) treatment - You are willing to have measurements taken and provide written consent - You are 18 or older **You may NOT be eligible if...** - You are under 18 years old - You are already receiving or need tube feeding or IV nutrition - You refuse to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.