Overview
GALENOS 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance
Description
This single-center prospective observational cohort study will enroll adult patients with pathologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment according to routine clinical practice. The study will longitudinally assess nutritional intake, anthropometric and body composition parameters, muscle function, circulating cytokines, quality of life, treatment-related toxicity, and treatment tolerance. Study procedures include dietary visits, 3-day food records, nutritional screening, bioimpedance analysis, handgrip testing, cytokine sampling, quality-of-life questionnaires, and collection of treatment adherence/tolerance data at predefined time points from baseline through follow-up. The study aims to generate observational data to inform future immunonutritional interventional studies
Eligibility
Inclusion Criteria:
- Written informed consent provided before study procedures
- Male or female participants aged 18 years or older
- Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer
- Candidate for standard antineoplastic treatment according to clinical practice
- ECOG Performance Status score less than 2
- Adequate kidney, liver, and bone marrow function
- Ability to adhere to study visits and protocol requirements
Exclusion Criteria:
- Incomplete recovery from surgery before start of antineoplastic treatment
- Other additional malignancies progressing or requiring active treatment within the previous 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 that would interfere with study compliance
- Receipt of any live vaccine within 30 days before planned start of study therapy
- Active cardiac pacing/pacing implants/neurostimulators/hearing systems not compatible with bioimpedance analysis
- Edema and/or ascites interfering with body weight evaluation or bioimpedance analysis
- Enteral or parenteral nutritional support at baseline
