Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Galenic Immunonutrition Formula
Dietary supplementThe investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Experimental: Galenic Immunonutrition FormulaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participants with at least 1 Grade 3 or higher treatment-related adverse event
Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Time frame
From the first day of antineoplastic treatment to end of trial, assessed up to 63 daysSecondary outcomes
1
Body weight
Body weight measured in kilograms (kg)
Time frame
From baseline (T0) to end of trial (T3), assessed up to 63 days2
Body mass index
Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)
Time frame
From baseline (T0) to end of trial (T3), assessed up to 63 days3
Daily oral energy intake
Average daily oral energy intake assessed from food record and expressed in kilocalories per day (kcal/day).
Time frame
From baseline (T0) to end of trial (T3), assessed up to 63 days4
Nutritional Risk Screening 2002 score
Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total score ranges from 0 to 7, with higher scores indicating greater nutritional risk and worse nutritional status
Time frame
From baseline (T0) to end of trial (T3), assessed up to 63 daysSponsors and contacts
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Source ClinicalTrials.gov