Improving tolerance to chemoradiotherapy in head and neck cancer patients with nutritional support
Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT04611113 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with head and neck cancer who are scheduled for curative or adjuvant chemoradiotherapy.
Not a fit: Patients under 18 years old or those requiring artificial nutrition will not benefit from this study.
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 performed: Previous studies have indicated that nutritional supplementation can positively impact recovery and treatment outcomes in cancer patients, suggesting a promising avenue for this approach.
Eligibility criteria
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 this trial is running
Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.