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Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
RECRUITING
Candiolo
Contact Information
Primary
Valentina Casalone, MD
valentina.casalone@ircc.it
0119933844
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 52
Treatments
Experimental: Experimental: Galenic Immunonutrition Formula
Participants with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment will receive the galenic immunonutrition formula twice daily from treatment start for a maximum of 45 days, alongside routine nutritional counseling and standard clinical management
Sponsors
Leads: Fondazione del Piemonte per l'Oncologia

This content was sourced from clinicaltrials.gov