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

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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Head and Neck Squamous Cell Carcinoma; Locally Advanced Rectal Cancer
• Intervention / Treatment: Dietary supplement: Galenic Immunonutrition Formula

Detailed Description

This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentina Casalone, MD; Phone Number: +39 0119933844; Email: valentina.casalone@ircc.it

Study Locations

• Italy
  • Torino (TO)
    • Candiolo, Torino (TO), Italy, 10060
      • Recruiting
      • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
      • Contact: Valentina Casalone; Phone Number: +39 0119933844; Email: valentina.casalone@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Dietary supplement: Galenic Immunonutrition Formula; The 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From the first day of antineoplastic treatment to end of trial, assessed up to 63 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight measured in kilograms (kg)	From baseline (T0) to end of trial (T3), assessed up to 63 days
Body mass index	Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)	From baseline (T0) to end of trial (T3), assessed up to 63 days
Daily oral energy intake	Average daily oral energy intake assessed from food record and expressed in kilocalories per day (kcal/day).	From baseline (T0) to end of trial (T3), assessed up to 63 days
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	From baseline (T0) to end of trial (T3), assessed up to 63 days
Prognostic Nutritional Index	Prognostic Nutritional Index (PNI). Higher values indicate better nutritional and immunologic status	From baseline (T0) to end of trial (T3), assessed up to 63 days
Participants requiring additional nutritional support	Number of participants requiring additional oral, enteral, or parenteral nutritional support during the study period	From the first day of treatment to end of trial, assessed up to 63 days
Skeletal muscle mass	Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg)	From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat-free mass	Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg).	From baseline (T0) to end of trial (T3), assessed up to 63 days
Body cell mass	Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg).	From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat mass	Fat mass measured by bioimpedance analysis and expressed in kilograms (kg).	From baseline (T0) to end of trial (T3), assessed up to 63 days
Total body water	Total body water measured by bioimpedance analysis and expressed in liters (L)	From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle index	Skeletal muscle index measured by bioimpedance analysis and expressed in kg/m²	From baseline (T0) to end of trial (T3), assessed up to 63 days
Phase angle	Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity	From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip strength	Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg).	From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance	Handgrip endurance measured using a handgrip dynamometer.	From baseline (T0) to end of trial (T3), assessed up to 63 days
ECOG Performance Status score	Performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. Scores range from 0 to 5, with higher scores indicating worse functional impairment	From baseline (T0) to end of trial (T3), assessed up to 63 days
Toxicity-free survival	Time from the first day of antineoplastic treatment to the first documented treatment-related adverse event, assessed according to CTCAE v5.0, expressed in days	From the first day of treatment to first toxicity or end of trial, assessed up to 63 days
Relative chemotherapy dose delivered	Total chemotherapy dose administered expressed as the percentage of the planned chemotherapy dose	From treatment start to end of treatment, assessed up to 63 days
Relative radiotherapy dose delivered	Total radiotherapy dose administered expressed as the percentage of the planned radiotherapy dose.	From treatment start to end of treatment, assessed up to 63 days
Relative immunotherapy dose delivered	Total immunotherapy dose administered expressed as the percentage of the planned immunotherapy dose.	From treatment start to end of treatment, assessed up to 63 days
Relative variation in treatment duration	Variation in actual treatment duration compared with planned treatment duration, expressed as a percentage	From treatment start to end of treatment, assessed up to 63 days
Participants completing the planned treatment schedule	Number of participants who complete the planned treatment schedule.	From treatment start to end of treatment, assessed up to 63 days
Participants requiring unplanned hospitalization	Number of participants requiring at least 1 unplanned hospitalization during the study period.	From treatment start to end of trial, assessed up to 63 days
EORTC QLQ-C30 Global Health Status / Quality of Life score	Self-perceived quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 version 3.0 (EORTC QLQ-C30 v3.0), Global Health Status / Quality of Life scale. Scores range from 0 to 100, with higher scores indicating better quality of life.	At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days
International Physical Activity Questionnaire score	Physical activity assessed using the International Physical Activity Questionnaire (IPAQ).	From baseline (T0) to end of trial (T3), assessed up to 63 days
Formula compliance	Compliance with the galenic immunonutrition formula, expressed as the percentage of prescribed daily servings recorded as consumed in the daily intake diary.	From the first day of treatment to Day 45, assessed up to 45 days
Change in circulating CCL2 concentration	Plasma CCL2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL4 concentration	Plasma CCL4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL22 concentration	Plasma CCL22 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CXCL10 concentration	Plasma CXCL10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IFN-γ concentration	Plasma IFN-γ concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-2 concentration	Plasma IL-2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-4 concentration	Plasma IL-4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-5 concentration	Plasma IL-5 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-6 concentration	Plasma IL-6 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-8 concentration	Plasma IL-8 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-10 concentration	Plasma IL-10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-12 concentration	Plasma IL-12 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-13 concentration	Plasma IL-13 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-15 concentration	Plasma IL-15 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TGF-β concentration	Plasma TGF-β concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TNF-α concentration	Plasma TNF-α concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in C-reactive protein concentration	C-reactive protein concentration measured in peripheral blood	From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Quality of Life; Supportive Care; Body Composition; Cytokines; Head and Neck Squamous Cell Carcinoma; Immunonutrition; Nutritional Status; Locally Advanced Rectal Cancer; Treatment Toxicity
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Lung Neoplasms
• Other Study ID Numbers: 006-FPO25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No