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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Galenic Immunonutrition Formula | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galenic Immunonutrition Formula | Dietary Supplement | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Casalone, MD | Contact | 0119933844 | +39 | valentina.casalone@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 | Recruiting | Candiolo | Torino (TO) | 10060 | Italy |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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All enrolled participants will receive the galenic immunonutrition formula in addition to standard nutritional care and standard oncologic treatment. Outcomes will be compared with control patients from the GALENOS 1 observational study using matching or pooling methods
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| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |