Head and Neck Squamous Cell CarcinomaLocally Advanced Rectal CancerLung Cancer
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Daily energy intake normalized to body weight — From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months Average daily oral energy intake assessed using a 3-day food record and expressed as kilocalories per kilogram of body weight per day (kcal/kg/day)
Skeletal muscle mass — From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg) the protocol states that phase angle may be used as an alternative depending on the BIA software
Handgrip strength — From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg)
Trial sites (1)
Facility
City
Region
Status
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo
Torino (TO)
Recruiting
More Fondazione del Piemonte per l'Oncologia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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