Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, Lung Cancer, Locally Advanced Rectal Cancer, Nutritional Status, Body Composition, Skeletal Muscle Mass, Sarcopenia, Bioimpedance Analysis, Handgrip Strength, Cytokines, Quality of Life, Treatment Toxicity, Treatment Tolerance, Immunonutrition, Supportive Care
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent provided before study procedures * Male or female participants aged 18 years or older * Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer * Candidate for standard antineoplastic treatment according to clinical practice * ECOG Performance Status score less than 2 * Adequate kidney, liver, and bone marrow function * Ability to adhere to study visits and protocol requirements
Exclusion criteria
* Incomplete recovery from surgery before start of antineoplastic treatment * Other additional malignancies progressing or requiring active treatment within the previous 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 that would interfere with study compliance * Receipt of any live vaccine within 30 days before planned start of study therapy * Active cardiac pacing/pacing implants/neurostimulators/hearing systems not compatible with bioimpedance analysis * Edema and/or ascites interfering with body weight evaluation or bioimpedance analysis * Enteral or parenteral nutritional support at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily energy intake normalized to body weight | From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months | 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) |
| Skeletal muscle mass | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | 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 |
| Handgrip strength | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Body weight measured in kilograms (kg) |
| Participants with more than 5% body weight loss | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Number of participants with body weight loss greater than 5% from baseline |
| Body mass index | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²) |
| Nutritional Risk Screening 2002 score | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | 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 |
| Prognostic Nutritional Index | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Prognostic Nutritional Index calculated as serum albumin + 5 × total lymphocyte count. Higher values indicate better nutritional/immunologic status |
| Phase angle | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity and nutritional status |
| Fat-free mass | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg) |
| Body cell mass | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg) |
| Fat mass | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Fat mass measured by bioimpedance analysis and expressed in kilograms (kg) |
| Total body water | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | Total body water measured by bioimpedance analysis and expressed in liters (L) |
| EORTC QLQ-C30 Global Health Status / Quality of Life score | From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months | 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. |
| Change in circulating CCL2 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma CCL2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating CCL4 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma CCL4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating CCL22 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma CCL22 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating CXCL10 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma CXCL10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating IL-2 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IL-4 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IL-5 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-5 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IL-6 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-6 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating IL-8 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-8 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IL-10 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IL-12 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-12 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating IL-15 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-15 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL) |
| Change in circulating IL-13 concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IL-13 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating TNF-α concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma TNF-α concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL). |
| Change in circulating IFN-γ concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma IFN-γ concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL |
| Change in circulating VEGF concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma VEGF concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL |
| Change in circulating TGF-β concentration | From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks | Plasma TGF-β concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL |
Countries
Italy
Contacts
CONTACTValentina Casalone, MD
Outcome results
None listed