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

Official title

An Observational Study on Longitudinal Nutritional Status and Body Composition Changes in Head and Neck Cancer, Lung Cancer and Rectal Cancer Patients During Antineoplastic Treatments

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

Detailed 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

Primary outcome measures

• Daily energy intake normalized to body weight [Time frame: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months]
• Skeletal muscle mass [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Handgrip strength [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]

Secondary outcome measures (12)

• Body weight [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Participants with more than 5% body weight loss [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Body mass index [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Nutritional Risk Screening 2002 score [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Prognostic Nutritional Index [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Phase angle [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Fat-free mass [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Body cell mass [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Fat mass [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Total body water [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• EORTC QLQ-C30 Global Health Status / Quality of Life score [Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Change in circulating CCL2 concentration [Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 — Candiolo

Identifiers

NCT: NCT07511413 · 003-FPO24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗