Actively Recruiting
Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-07
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a galenic immunonutrition dietary supplement in adults with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are undergoing standard cancer treatments like chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy. This phase II interventional study aims to see if the supplement can reduce treatment-related side effects and improve how well patients stick to their treatment plans, comparing results to a previous observational study group. Participants will take a specially formulated galenic immunonutrition jelly twice daily starting on the first day of their cancer treatment and continue for up to 45 days. Alongside this supplement, they will receive standard nutritional counseling and routine cancer care. The study is single-arm and conducted at a single center, focusing on how the supplement works as part of their ongoing treatment. During the study, participants will be closely monitored for treatment-related side effects, nutritional status, body composition, muscle function, immune system markers, quality of life, physical activity, and how well they tolerate both the cancer treatment and the supplement. Researchers will measure various health and treatment adherence outcomes up to 63 days from the start of treatment, including detailed blood tests and assessments of physical strength and performance. The overall participation may last up to about two months, with safety and treatment compliance carefully tracked.
CONDITIONS
Brief Title
Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for study procedures
- Male or female aged over 18 years
- Diagnosed with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer
- Candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard care
- ECOG Performance Status score less than 2
- Adequate kidney, liver, and bone marrow function
- Able to understand, sign consent, and follow study procedures
You will not qualify if you...
- Not fully recovered from surgery before starting cancer treatment
- Other active or progressing cancers needing treatment within the last 3 years, except certain localized skin cancers or cervical carcinoma in situ
- Active infection requiring systemic antibiotics
- Serious or unstable medical conditions, psychiatric disorders, or substance abuse affecting study participation
- Received any live vaccine within 30 days before starting study treatment
- Have active cardiac pacing devices, neurostimulators, or incompatible hearing systems
- Edema or ascites affecting body weight evaluation and bioimpedance analysis
- Receiving enteral or parenteral nutritional support at study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 45 days
Participants receive the galenic immunonutrition formula twice daily starting on the first day of their antineoplastic treatment, alongside standard nutritional counseling and routine oncologic care.
Visits occur during the treatment period as part of routine oncologic care
Duration - Up to 18 days after treatment (up to 63 days total from treatment start)
Participants are monitored for treatment-related toxicities, nutritional status, quality of life, and other health outcomes after completing the immunonutrition treatment.
Follow-up assessments occur up to the end of trial period
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
Research Team
V
Valentina Casalone, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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