Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Galenic Immunonutrition Formula
Treatment groups
52 Participants
are divided into 1 treatment groupLocations
1Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 1006010060, CandioloTorino (TO), Italy
Sponsors and collaborators
Fondazione del Piemonte per l'Oncologia
Lead sponsor
Source ClinicalTrials.gov