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NCT Number: NCT07511413

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

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

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Atrophy Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Locally Advanced Rectal Cancer Lung Cancer Lung Diseases Lung Neoplasms Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcopenia Signs and Symptoms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060

Candiolo, Torino (TO), 10060, Italy

Location status: Recruiting

Location contact

Valentina Casalone, MD

CONTACT

[email protected]

0119933422

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Daily energy intake normalized to body weight

    Time frame: 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)

  2. Skeletal muscle mass

    Time frame: 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

  3. Handgrip strength

    Time frame: 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 outcomes

  1. Body weight

    Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months

    Body weight measured in kilograms (kg)

  2. Participants with more than 5% body weight loss

    Time frame: 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

  3. Body mass index

    Time frame: 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)

  4. Nutritional Risk Screening 2002 score

    Time frame: 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

  5. Prognostic Nutritional Index

    Time frame: 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

  6. Phase angle

    Time frame: 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

  7. Fat-free mass

    Time frame: 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)

  8. Body cell mass

    Time frame: 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)

  9. Fat mass

    Time frame: 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)

  10. Total body water

    Time frame: 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)

  11. EORTC QLQ-C30 Global Health Status / Quality of Life score

    Time frame: 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.

  12. Change in circulating CCL2 concentration

    Time frame: 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)

  13. Change in circulating CCL4 concentration

    Time frame: 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)

  14. Change in circulating CCL22 concentration

    Time frame: 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)

  15. Change in circulating CXCL10 concentration

    Time frame: 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)

  16. Change in circulating IL-2 concentration

    Time frame: 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).

  17. Change in circulating IL-4 concentration

    Time frame: 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).

  18. Change in circulating IL-5 concentration

    Time frame: 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).

  19. Change in circulating IL-6 concentration

    Time frame: 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)

  20. Change in circulating IL-8 concentration

    Time frame: 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).

  21. Change in circulating IL-10 concentration

    Time frame: 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).

  22. Change in circulating IL-12 concentration

    Time frame: 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)

  23. Change in circulating IL-15 concentration

    Time frame: 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)

  24. Change in circulating IL-13 concentration

    Time frame: 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).

  25. Change in circulating TNF-α concentration

    Time frame: 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).

  26. Change in circulating IFN-γ concentration

    Time frame: 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

  27. Change in circulating VEGF concentration

    Time frame: 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

  28. Change in circulating TGF-β concentration

    Time frame: 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

Other outcomes

  1. Change in C-reactive protein concentration

    Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks

    C-reactive protein concentration measured in peripheral blood

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Casalone, MD

CONTACT

[email protected]

0119933422 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

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

Acronym: GALENOS 1

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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