Clinical trial · Observational
GALENOS 1 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
- 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 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Head and Neck Squamous Cell Carcinoma Cohort
- description
- Patients with pathologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, or sinus cancer) who are candidates for curative or adjuvant chemoradiotherapy according to standard clinical practice
- label
- Locally Advanced Rectal Cancer Cohort
- description
- Patients with pathologically confirmed locally advanced rectal cancer who are candidates for neoadjuvant chemoradiotherapy according to standard clinical practice
- label
- Lung Cancer Cohort
- description
- Patients with pathologically or cytologically confirmed lung cancer who are candidates for curative immunotherapy with or without chemotherapy according to standard clinical practice
Primary outcomes (3)
- measure
- Daily energy intake normalized to body weight
- timeFrame
- From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available