Galenos 2: Immunonutrition for head and neck, lung, and rectal cancer patients
Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study
This trial tests whether taking a twice-daily galenic immunonutrition supplement can reduce side effects and help people with head and neck, lung, or locally advanced rectal cancer complete their cancer therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Candiolo, Torino (TO)) |
| Trial ID | NCT07514754 on ClinicalTrials.gov |
What this trial studies
GALENOS 2 is a single-arm, single-center phase II interventional trial enrolling adults with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are starting standard chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy. All participants will receive a galenic immunonutrition formula twice daily from the first day of antineoplastic treatment for up to 45 days alongside standard nutritional counseling and routine oncologic care. The study will prospectively track treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, and treatment adherence. Outcomes will be compared with matched or pooled control patients from the prior GALENOS 1 observational cohort to estimate any differences in toxicity and treatment compliance.
Who should consider this trial
Good fit: Ideal candidates are adults with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are starting standard antineoplastic therapy, have ECOG performance status less than 2, and have adequate kidney, liver, and bone marrow function.
Not a fit: Patients with incomplete recovery from recent surgery, active infections requiring systemic antibiotics, other progressing malignancies requiring treatment, serious unstable medical or psychiatric conditions, or poor performance status are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the formula could lower treatment-related side effects, improve nutritional and functional status, and increase the likelihood patients complete their planned cancer therapy.
How similar studies have performed: Previous immunonutrition trials, mainly in the perioperative setting, have shown benefits for surgical outcomes and nutritional markers, but evidence for reducing toxicity during chemoradiotherapy is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent to study procedures * Male or female, age greater than 18 years * Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice * ECOG Performance Status score less than 2 * Adequate kidney, liver, and bone marrow function * Ability to understand, sign informed consent, and comply with study procedures Exclusion Criteria: * Incomplete recovery from surgery before starting antineoplastic treatment * Other progressing malignancy or malignancy requiring active treatment within the last 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 interfering with study compliance * Receipt of any live vaccine within 30 days before study treatment * Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis * Edema and/or ascites not compatible with body weight evaluation and 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: 0119933844
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.