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Taking people in ItalyNo phase

Follows nutrition and body changes in people with head, neck, lung or rectal cancer

Observes nutrition and body composition over time in adults with cancer during treatment.

Plain-language title generated from the registry record
Registry title: GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients

Key facts

Where
Candiolo, ItalySee the site

Where in Italy

  • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060Candiolo, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Fondazione del Piemonte per l'Oncologia
Trial code
NCT07511413
Record updated
6 April 2026
Original description
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 complianceRead full original descriptionShow less

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

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

Inclusion: 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: 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; 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; Edema and/or ascites interfering with body weight evaluation or bioimpedance analysis; Enteral or parenteral nutritional support at baseline.

ClinicalTrials.gov NCT07511413