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NCT Number: NCT07514754

Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients

GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Locally Advanced Rectal Cancer Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

CONTACT

[email protected]

0119933844 ext. +39

About this study

This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent to study procedures
  • Male or female, age greater than 18 years
  • Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice
  • ECOG Performance Status score less than 2
  • Adequate kidney, liver, and bone marrow function
  • Ability to understand, sign informed consent, and comply with study procedures

Exclusion criteria

  • Incomplete recovery from surgery before starting antineoplastic treatment
  • Other progressing malignancy or malignancy requiring active treatment within the last 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 interfering with study compliance
  • Receipt of any live vaccine within 30 days before study treatment
  • Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis
  • Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis
  • Enteral or parenteral nutritional support at baseline

Treatment and study plan

Galenic Immunonutrition Formula

Dietary Supplement

The investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo

Primary outcomes

  1. Participants with at least 1 Grade 3 or higher treatment-related adverse event

    Time frame: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days

    Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Secondary outcomes

  1. Body weight

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Body weight measured in kilograms (kg)

  2. Body mass index

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)

  3. Daily oral energy intake

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Average daily oral energy intake assessed from food record and expressed in kilocalories per day (kcal/day).

  4. Nutritional Risk Screening 2002 score

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total score ranges 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 end of trial (T3), assessed up to 63 days

    Prognostic Nutritional Index (PNI). Higher values indicate better nutritional and immunologic status

  6. Participants requiring additional nutritional support

    Time frame: From the first day of treatment to end of trial, assessed up to 63 days

    Number of participants requiring additional oral, enteral, or parenteral nutritional support during the study period

  7. Skeletal muscle mass

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg)

  8. Fat-free mass

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg).

  9. Body cell mass

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg).

  10. Fat mass

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Fat mass measured by bioimpedance analysis and expressed in kilograms (kg).

  11. Total body water

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Total body water measured by bioimpedance analysis and expressed in liters (L)

  12. Skeletal muscle index

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Skeletal muscle index measured by bioimpedance analysis and expressed in kg/m²

  13. Phase angle

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity

  14. Handgrip strength

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg).

  15. Handgrip endurance

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Handgrip endurance measured using a handgrip dynamometer.

  16. ECOG Performance Status score

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. Scores range from 0 to 5, with higher scores indicating worse functional impairment

  17. Toxicity-free survival

    Time frame: From the first day of treatment to first toxicity or end of trial, assessed up to 63 days

    Time from the first day of antineoplastic treatment to the first documented treatment-related adverse event, assessed according to CTCAE v5.0, expressed in days

  18. Relative chemotherapy dose delivered

    Time frame: From treatment start to end of treatment, assessed up to 63 days

    Total chemotherapy dose administered expressed as the percentage of the planned chemotherapy dose

  19. Relative radiotherapy dose delivered

    Time frame: From treatment start to end of treatment, assessed up to 63 days

    Total radiotherapy dose administered expressed as the percentage of the planned radiotherapy dose.

  20. Relative immunotherapy dose delivered

    Time frame: From treatment start to end of treatment, assessed up to 63 days

    Total immunotherapy dose administered expressed as the percentage of the planned immunotherapy dose.

  21. Relative variation in treatment duration

    Time frame: From treatment start to end of treatment, assessed up to 63 days

    Variation in actual treatment duration compared with planned treatment duration, expressed as a percentage

  22. Participants completing the planned treatment schedule

    Time frame: From treatment start to end of treatment, assessed up to 63 days

    Number of participants who complete the planned treatment schedule.

  23. Participants requiring unplanned hospitalization

    Time frame: From treatment start to end of trial, assessed up to 63 days

    Number of participants requiring at least 1 unplanned hospitalization during the study period.

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

    Time frame: At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days

    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 quality of life.

  25. International Physical Activity Questionnaire score

    Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days

    Physical activity assessed using the International Physical Activity Questionnaire (IPAQ).

  26. Formula compliance

    Time frame: From the first day of treatment to Day 45, assessed up to 45 days

    Compliance with the galenic immunonutrition formula, expressed as the percentage of prescribed daily servings recorded as consumed in the daily intake diary.

  27. Change in circulating CCL2 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma CCL2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  28. Change in circulating CCL4 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma CCL4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  29. Change in circulating CCL22 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma CCL22 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  30. Change in circulating CXCL10 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma CXCL10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  31. Change in circulating IFN-γ concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IFN-γ concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  32. Change in circulating IL-2 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  33. Change in circulating IL-4 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  34. Change in circulating IL-5 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-5 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  35. Change in circulating IL-6 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-6 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  36. Change in circulating IL-8 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-8 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  37. Change in circulating IL-10 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  38. Change in circulating IL-12 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-12 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  39. Change in circulating IL-13 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-13 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  40. Change in circulating IL-15 concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma IL-15 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  41. Change in circulating TGF-β concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma TGF-β concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  42. Change in circulating TNF-α concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    Plasma TNF-α concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).

  43. Change in C-reactive protein concentration

    Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

    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]

0119933844 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study

Acronym: GALENOS 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 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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