GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients
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 observati
| Condition(s) | Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione del Piemonte per l'Oncologia |
| Locations | Candiolo, Torino (TO), Italy |
| Start date | 2024-09-23 |
| NCT ID | NCT07511413 |
| Official listing | https://clinicaltrials.gov/study/NCT07511413 |