GALENOS 1: Longitudinal nutrition and body composition in head and neck, lung, and rectal cancer patients
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
Fondazione del Piemonte per l'Oncologia · NCT07511413
This project will see how nutritional status and body composition change over time in adults with head and neck, lung, or locally advanced rectal cancer who are receiving standard anticancer treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia (other) |
| Locations | 1 site (Candiolo, Torino (TO)) |
| Trial ID | NCT07511413 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically or cytologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment, have ECOG PS <2, adequate organ function, and can attend scheduled visits are ideal.
Not a fit: Patients with rapidly progressing or untreated additional malignancies, active infections requiring systemic antibiotics, incomplete recovery from surgery, poor performance status, or inability to adhere to visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the data could help design an immunonutrition supplement that reduces treatment-related adverse events and improves patients' ability to complete cancer therapy.
How similar studies have performed: Previous work on nutritional monitoring and immunonutrition in surgical and some oncology settings has shown benefits for complications and recovery, but using a specific galenic immunonutrition supplement in these cancer populations is novel and preparatory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Candiolo, Torino (TO)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer, Nutritional Status, Body Composition, Skeletal Muscle Mass, Sarcopenia, Bioimpedance Analysis