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

Official title

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

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

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 supplement Galenic 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

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Body weight [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Body mass index [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Daily oral energy intake [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Nutritional Risk Screening 2002 score [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Prognostic Nutritional Index [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Participants requiring additional nutritional support [Time frame: From the first day of treatment to end of trial, assessed up to 63 days]
• Skeletal muscle mass [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Fat-free mass [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Body cell mass [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Fat mass [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Total body water [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]
• Skeletal muscle index [Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 1 center

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

Identifiers

NCT: NCT07514754 · 006-FPO25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗