GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients (GALENOS 1)

An Observational Study on Longitudinal Nutritional Status and Body Composition Changes in Head and Neck Cancer, Lung Cancer and Rectal Cancer Patients During Antineoplastic Treatments

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Head and Neck Squamous Cell Carcinoma; Locally Advanced Rectal Cancer

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

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Valentina Casalone, MD; Phone Number: +39 0119933422; Email: valentina.casalone@ircc.it

Study Locations

• Italy
  • Torino (TO)
    • Candiolo, Torino (TO), Italy, 10060
      • Recruiting
      • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
      • Contact: Valentina Casalone, MD; Phone Number: 0119933422; Email: valentina.casalone@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Quality of Life; Supportive Care; Body Composition; Sarcopenia; Cytokines; Head and Neck Squamous Cell Carcinoma; Immunonutrition; Nutritional Status; Handgrip Strength; Locally Advanced Rectal Cancer; Bioimpedance Analysis; Skeletal Muscle Mass; Treatment Toxicity; Treatment Tolerance
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Lung Neoplasms; Sarcopenia
• Other Study ID Numbers: 003-FPO24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No