NCT04611113 Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer
| NCT ID | NCT04611113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2021-03-17 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2021-03-17 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Riccardo Caccialanza, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Policlinico San Matteo
Frequently Asked Questions
Who can join the NCT04611113 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04611113 currently recruiting?
Yes, NCT04611113 is actively recruiting participants. Contact the research team at r.caccialanza@smatteo.pv.it for enrollment information.
Where is the NCT04611113 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT04611113 clinical trial?
NCT04611113 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The principal investigator is Riccardo Caccialanza, MD at Fondazione IRCCS Policlinico San Matteo. The trial plans to enroll 86 participants.
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