An interventional study of Galenic Immunonutrition Formula in Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer and Lung Cancer, sponsored by Fondazione del Piemonte per l'Oncologia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Fondazione del Piemonte per l'Oncologia · Not applicable, Interventional, and Supportive care
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
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
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 52 is close to the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Fondazione del Piemonte per l'Oncologia is the lead sponsor of 39 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
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 days
Body weight
Body weight measured in kilograms (kg)
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance
Handgrip endurance measured using a handgrip dynamometer.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
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Fondazione del Piemonte per l'Oncologia