GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients

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

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

Conditions4

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