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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Daily energy intake normalized to body weight
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lung Cancer Cohort
Patients with pathologically or cytologically confirmed lung cancer who are candidates for curative immunotherapy with or without chemotherapy according to standard clinical practice
Head and Neck Squamous Cell Carcinoma Cohort
Patients with pathologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, or sinus cancer) who are candidates for curative or adjuvant chemoradiotherapy according to standard clinical practice
Locally Advanced Rectal Cancer Cohort
Patients with pathologically confirmed locally advanced rectal cancer who are candidates for neoadjuvant chemoradiotherapy according to standard clinical practice
结局指标
主要结局
Daily energy intake normalized to body weight
时间窗: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months
Average daily oral energy intake assessed using a 3-day food record and expressed as kilocalories per kilogram of body weight per day (kcal/kg/day)
Skeletal muscle mass
时间窗: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg) the protocol states that phase angle may be used as an alternative depending on the BIA software
Handgrip strength
时间窗: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg)
次要结局
- Body weight(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Participants with more than 5% body weight loss(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Body mass index(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Nutritional Risk Screening 2002 score(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Prognostic Nutritional Index(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Phase angle(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Fat-free mass(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Body cell mass(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Fat mass(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Total body water(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- EORTC QLQ-C30 Global Health Status / Quality of Life score(From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months)
- Change in circulating CCL2 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating CCL4 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating CCL22 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating CXCL10 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-2 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-4 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-5 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-6 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-8 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-10 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-12 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-15 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IL-13 concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating TNF-α concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating IFN-γ concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating VEGF concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)
- Change in circulating TGF-β concentration(From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks)