Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients

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 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

Conditions4

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