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GALENOS 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance
This single-center prospective observational cohort study will enroll adult patients with pathologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment according to routine clinical practice. The study will longitudinally assess nutritional intake, anthropometric and body composition parameters, muscle function, circulating cytokines, quality of life, treatment-related toxicity, and treatment tolerance. Study procedures include dietary visits, 3-day food records, nutritional screening, bioimpedance analysis, handgrip testing, cytokine sampling, quality-of-life questionnaires, and collection of treatment adherence/tolerance data at predefined time points from baseline through follow-up. The study aims to generate observational data to inform future immunonutritional interventional studies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma Cohort | Patients with pathologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, or sinus cancer) who are candidates for curative or adjuvant chemoradiotherapy according to standard clinical practice | ||
| Locally Advanced Rectal Cancer Cohort | Patients with pathologically confirmed locally advanced rectal cancer who are candidates for neoadjuvant chemoradiotherapy according to standard clinical practice | ||
| Lung Cancer Cohort | Patients with pathologically or cytologically confirmed lung cancer who are candidates for curative immunotherapy with or without chemotherapy according to standard clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Daily energy intake normalized to body weight | Average daily oral energy intake assessed using a 3-day food record and expressed as kilocalories per kilogram of body weight per day (kcal/kg/day) | From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months |
| Skeletal muscle mass | Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg) the protocol states that phase angle may be used as an alternative depending on the BIA software | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Handgrip strength | Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight measured in kilograms (kg) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Participants with more than 5% body weight loss | Number of participants with body weight loss greater than 5% from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive protein concentration | C-reactive protein concentration measured in peripheral blood | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with histologically or cytologically documented head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment at Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo and meet protocol eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Casalone, MD | Contact | 0119933422 | +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 |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Peripheral blood/plasma samples collected at baseline and end of treatment for cytokine analyses
| From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Body mass index | Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Nutritional Risk Screening 2002 score | Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total scores range from 0 to 7, with higher scores indicating greater nutritional risk and worse nutritional status | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Prognostic Nutritional Index | Prognostic Nutritional Index calculated as serum albumin + 5 × total lymphocyte count. Higher values indicate better nutritional/immunologic status | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Phase angle | Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity and nutritional status | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Fat-free mass | Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Body cell mass | Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Fat mass | Fat mass measured by bioimpedance analysis and expressed in kilograms (kg) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| Total body water | Total body water measured by bioimpedance analysis and expressed in liters (L) | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| 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 global health status and quality of life. | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| Change in circulating VEGF concentration | Plasma VEGF concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks |
| 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 |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |