Overview
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
Description
This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study
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
