Actively Recruiting

Age: 18Years +
All Genders
NCT07511413

GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-06

110

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

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

CONDITIONS

Official Title

GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Candiolo, Torino (TO), Italy, 10060

Actively Recruiting

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Research Team

V

Valentina Casalone, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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