NCT07511413Recruiting
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 · Last updated 6 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- 23 Sept 2024
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT07511413
What you commit to
- Study type: Observational
- Planned participants: 110
- From 23 Sept 2024 to the primary completion date, 30 Aug 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 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
- Receipt of any live vaccine within 30 days before planned start of study therapy
Other illness
- Active infection requiring systemic antibiotic therapy Serious or unstable medical conditions, psychiatric disorders, or substance abuse that would interfere with study compliance
- Active cardiac pacing/pacing implants/neurostimulators/hearing systems not compatible with bioimpedance analysis
Other
- Edema and/or ascites interfering with body weight evaluation or bioimpedance analysis
- Enteral or parenteral nutritional support at baseline
Who the study is looking for
- 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
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.