Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer
Conditions
Keywords
Immunonutrition, Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer, Treatment Toxicity, Supportive Care, Body Composition, Nutritional Status, Cytokines, Quality of Life
Brief summary
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
Detailed description
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
Interventions
DIETARY_SUPPLEMENTGalenic Immunonutrition Formula
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
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All enrolled participants will receive the galenic immunonutrition formula in addition to standard nutritional care and standard oncologic treatment. Outcomes will be compared with control patients from the GALENOS 1 observational study using matching or pooling methods
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants with at least 1 Grade 3 or higher treatment-related adverse event | 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
| Measure | Time frame | Description |
|---|---|---|
| Body weight | From baseline (T0) to end of trial (T3), assessed up to 63 days | Body weight measured in kilograms (kg) |
| Body mass index | 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) |
| Daily oral energy intake | 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). |
| Nutritional Risk Screening 2002 score | 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 |
| Prognostic Nutritional Index | 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 |
| Participants requiring additional nutritional support | 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 |
| Skeletal muscle mass | 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) |
| Fat-free mass | 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). |
| Body cell mass | 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). |
| Fat mass | From baseline (T0) to end of trial (T3), assessed up to 63 days | Fat mass measured by bioimpedance analysis and expressed in kilograms (kg). |
| Total body water | 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) |
| Skeletal muscle index | 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 |
| Phase angle | 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 |
| Handgrip strength | 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). |
| Handgrip endurance | From baseline (T0) to end of trial (T3), assessed up to 63 days | Handgrip endurance measured using a handgrip dynamometer. |
| ECOG Performance Status score | 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 |
| Toxicity-free survival | 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 |
| Relative chemotherapy dose delivered | 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 |
| Relative radiotherapy dose delivered | 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. |
| Relative immunotherapy dose delivered | 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. |
| Relative variation in treatment duration | 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 |
| Participants completing the planned treatment schedule | From treatment start to end of treatment, assessed up to 63 days | Number of participants who complete the planned treatment schedule. |
| Participants requiring unplanned hospitalization | 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. |
| EORTC QLQ-C30 Global Health Status / Quality of Life score | 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. |
| International Physical Activity Questionnaire score | From baseline (T0) to end of trial (T3), assessed up to 63 days | Physical activity assessed using the International Physical Activity Questionnaire (IPAQ). |
| Formula compliance | 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. |
| Change in circulating CCL2 concentration | 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). |
| Change in circulating CCL4 concentration | 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). |
| Change in circulating CCL22 concentration | 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). |
| Change in circulating CXCL10 concentration | 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). |
| Change in circulating IFN-γ concentration | 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). |
| Change in circulating IL-2 concentration | 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). |
| Change in circulating IL-4 concentration | 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). |
| Change in circulating IL-5 concentration | 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). |
| Change in circulating IL-6 concentration | 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). |
| Change in circulating IL-8 concentration | 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). |
| Change in circulating IL-10 concentration | 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). |
| Change in circulating IL-12 concentration | 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). |
| Change in circulating IL-13 concentration | 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). |
| Change in circulating IL-15 concentration | 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). |
| Change in circulating TGF-β concentration | 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). |
| Change in circulating TNF-α concentration | 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). |
| Change in C-reactive protein concentration | 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 |
Countries
Italy
Contacts
CONTACTValentina Casalone, MD
Outcome results
None listed