GALENOS 1: Longitudinal nutrition and body composition in head and neck, lung, and rectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GALENOS 1 is a single-center prospective observational cohort enrolling adults with pathologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are planned for standard antineoplastic treatment. Participants will have repeated dietary visits, 3-day food records, nutritional screening, bioimpedance analysis, handgrip testing, blood cytokine sampling, quality-of-life questionnaires, and recording of treatment toxicity and tolerance at predefined time points from baseline through follow-up. The study collects longitudinal, real-world data to characterize changes in intake, body composition, muscle function, inflammation, and treatment adherence. These observational data will inform the design of future interventional studies of a galenic immunonutrition supplement within the FOR-GALE PREVENTION program.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
  Candiolo, Torino (TO), Italy Recruiting

Study contacts

• Study coordinator: Valentina Casalone, MD
• Email: valentina.casalone@ircc.it
• Phone: 0119933422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.