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
Study Type
OBSERVATIONAL
Enrollment
110
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), Italy
RECRUITINGDaily 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)
Time frame: 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
Time frame: 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)
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Body weight
Body weight measured in kilograms (kg)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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