Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study
Fondazione del Piemonte per l'Oncologia
52 participants
Oct 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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
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Interventions
The investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07514754