RecruitingNot Applicable

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

Italy110 participantsStarted 2024-09-23

Plain-language 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

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 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

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

Daily energy intake normalized to body weight

Timeframe: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months

Skeletal muscle mass

Timeframe: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months

Handgrip strength

Timeframe: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months

Trial details

NCT IDNCT07511413

SponsorFondazione del Piemonte per l'Oncologia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-08-30

Contact for this trial

Valentina Casalone, MD

0119933422 valentina.casalone@ircc.it

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

Plain-language summary

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.

What they're measuring

Daily energy intake normalized to body weight

Timeframe: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months

Skeletal muscle mass

Timeframe: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months

Handgrip strength

Timeframe: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months