GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients
Recruiting · NCT07511413 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 - Candiolo, Torino (TO), Italy