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

Fondazione del Piemonte per l'Oncologia52 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Galenic Immunonutrition FormulaDIETARY_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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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

Secondary Outcomes

Body weight

Body weight measured in kilograms (kg)

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

Body mass index

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

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

Daily oral energy intake

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

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

Nutritional Risk Screening 2002 score

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

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

Prognostic Nutritional Index

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

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

Participants requiring additional nutritional support

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

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

Skeletal muscle mass

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

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

Fat-free mass

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

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

Body cell mass

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

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

Fat mass

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

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

Total body water

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

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

Skeletal muscle index

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

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

Phase angle

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

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

Handgrip strength

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

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

Handgrip endurance

Handgrip endurance measured using a handgrip dynamometer.

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

ECOG Performance Status score

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

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

Toxicity-free survival

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

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

Relative chemotherapy dose delivered

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

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

Relative radiotherapy dose delivered

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

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

Relative immunotherapy dose delivered

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

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

Relative variation in treatment duration

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

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

Participants completing the planned treatment schedule

Number of participants who complete the planned treatment schedule.

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

Participants requiring unplanned hospitalization

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

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

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 quality of life.

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

International Physical Activity Questionnaire score

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

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

Formula compliance

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

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

Change in circulating CCL2 concentration

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