NCT07514754Recruiting
Galenos 2 Immunonutrition in 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
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 3 Oct 2025
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT07514754
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 3 Oct 2025 to the primary completion date, 30 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete recovery from surgery before starting antineoplastic treatment
- Receipt of any live vaccine within 30 days before study treatment
Other illness
- 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
- Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis
Other
- Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis
- Enteral or parenteral nutritional support at baseline
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.