Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving tolerance to chemoradiotherapy in head and neck cancer patients with nutritional support

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

Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT04611113 · Data updated 2026-11-12

This study is testing if a special nutritional drink can help people with head and neck cancer handle their chemoradiotherapy better than a regular nutritional drink.

More Head and Neck Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment86 (estimated)
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Academic / other
Locations1 site (Pavia)
StatusRecruiting
StartedMarch 17, 2021
Main results expectedNovember 15, 2026
Study endsNovember 15, 2026
Registry record updatedMay 1, 2025
Trial IDNCT04611113 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults diagnosed with head and neck cancer who are scheduled for curative or adjuvant chemoradiotherapy.

Probably not a fit

Patients under 18 years old or those requiring artificial nutrition will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effectiveness of oral nutritional supplementation enriched with immunonutrients compared to a standard nutritional blend in enhancing tolerance to chemoradiotherapy in patients with head and neck cancer. The study is a randomized, controlled, open-label pilot involving two parallel treatment groups. It aims to assess how these nutritional interventions, combined with counseling, can improve nutritional status, quality of life, and treatment feasibility during chemoradiotherapy. The focus is on the potential benefits of high-protein, high-calorie mixtures that may modulate inflammation and support recovery.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment tolerance and quality of life for patients undergoing chemoradiotherapy for head and neck cancer.

How similar studies have gone: Previous studies have indicated that nutritional supplementation can positively impact recovery and treatment outcomes in cancer patients, suggesting a promising avenue for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

  • Fondazione IRCCS Policlinico San Matteo
    Pavia, Italy
    Recruiting

Study contacts

  • Principal investigator: Riccardo Caccialanza, MD — Fondazione IRCCS Policlinico San Matteo
  • Study coordinator: Riccardo Caccialanza, MD
  • Email: r.caccialanza@smatteo.pv.it
  • Phone: 0382501615

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.