Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Galenic Immunonutrition Formula | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Galenic Immunonutrition Formula
- description
- Participants with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment will receive the galenic immunonutrition formula twice daily from treatment start for a maximum of 45 days, alongside routine nutritional counseling and standard clinical management
- interventionNames
- Dietary Supplement: Galenic Immunonutrition Formula
Primary outcomes (1)
- measure
- Participants with at least 1 Grade 3 or higher treatment-related adverse event
- timeFrame
- From the first day of antineoplastic treatment to end of trial, assessed up to 63 days
- description
- Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Secondary outcomes (43)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available