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

Официальное название

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

Обзор

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

Подробное описание

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

Первичные конечные точки

• Daily energy intake normalized to body weight [Срок оценки: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months]
• Skeletal muscle mass [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Handgrip strength [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]

Вторичные конечные точки (12)

• Body weight [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Participants with more than 5% body weight loss [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Body mass index [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Nutritional Risk Screening 2002 score [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Prognostic Nutritional Index [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Phase angle [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Fat-free mass [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Body cell mass [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Fat mass [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Total body water [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• EORTC QLQ-C30 Global Health Status / Quality of Life score [Срок оценки: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months]
• Change in circulating CCL2 concentration [Срок оценки: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

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

Идентификаторы

NCT: NCT07511413 · 003-FPO24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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