RecruitingNot Applicable

Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients

Italy52 participantsStarted 2025-10-03

Plain-language summary

GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants with at least 1 Grade 3 or higher treatment-related adverse event

Timeframe: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days

Trial details

NCT IDNCT07514754

SponsorFondazione del Piemonte per l'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Valentina Casalone, MD

0119933844 valentina.casalone@ircc.it

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials