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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Status | Recruiting |
| Started | March 17, 2021 |
| Main results expected | November 15, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | May 1, 2025 |
| Trial ID | NCT04611113 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.