NCT07514754 Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
| NCT ID | NCT07514754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione del Piemonte per l'Oncologia |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2027-07-30 |
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 52 participants in total. It began in 2025-10-03 with a primary completion date of 2027-07-30.
⚠ 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
GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison
Eligibility Criteria
Inclusion Criteria: * Written informed consent to study procedures * Male or female, age greater than 18 years * Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice * ECOG Performance Status score less than 2 * Adequate kidney, liver, and bone marrow function * Ability to understand, sign informed consent, and comply with study procedures Exclusion Criteria: * Incomplete recovery from surgery before starting antineoplastic treatment * Other progressing malignancy or malignancy requiring active treatment within the last 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ * Active infection requiring systemic antibiotic therapy * Serious or unstable medical conditions, psychiatric disorders, or substance abuse interfering with study compliance * Receipt of any live vaccine within 30 days before study treatment * Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis * Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis * Enteral or parenteral nutritional support at baseline
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07514754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07514754 currently recruiting?
Yes, NCT07514754 is actively recruiting participants. Contact the research team at valentina.casalone@ircc.it for enrollment information.
Where is the NCT07514754 trial being conducted?
This trial is being conducted at Candiolo, Italy.
Who is sponsoring the NCT07514754 clinical trial?
NCT07514754 is sponsored by Fondazione del Piemonte per l'Oncologia. The trial plans to enroll 52 participants.