Actively Recruiting
Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-07
52
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), Italy, 10060
Actively Recruiting
Research Team
V
Valentina Casalone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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