Galenos 2: Immunonutrition for head and neck, lung, and rectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GALENOS 2 is a single-arm, single-center phase II interventional trial enrolling adults with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are starting standard chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy. All participants will receive a galenic immunonutrition formula twice daily from the first day of antineoplastic treatment for up to 45 days alongside standard nutritional counseling and routine oncologic care. The study will prospectively track treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, and treatment adherence. Outcomes will be compared with matched or pooled control patients from the prior GALENOS 1 observational cohort to estimate any differences in toxicity and treatment compliance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent to study procedures
* Male or female, age greater than 18 years
* Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice
* ECOG Performance Status score less than 2
* Adequate kidney, liver, and bone marrow function
* Ability to understand, sign informed consent, and comply with study procedures

Exclusion Criteria:

* Incomplete recovery from surgery before starting antineoplastic treatment
* Other progressing malignancy or malignancy requiring active treatment within the last 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 interfering with study compliance
* Receipt of any live vaccine within 30 days before study treatment
* Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis
* Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis
* Enteral or parenteral nutritional support at baseline

Where it's running

• Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
  Candiolo, Torino (TO), Italy Recruiting

Study contacts

• Study coordinator: Valentina Casalone, MD
• Email: valentina.casalone@ircc.it
• Phone: 0119933844

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.