NCT06207708已完成不适用
Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated with Curative Hadrontherapy: a Prospective Monoinstitutional Study
CNAO National Center of Oncological Hadrontherapy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- skeletal muscle strength mass (SMM)
研究概览
简要总结
The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.
详细描述
To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:
- Acute toxicity: within 3 months from the beginning of particle RT
- Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional
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
- •All HNC histologies and stages
- •Histological and/or radiological diagnosis of head and neck tumors
- •The patient is able to give consent
- •Definitive/postoperative treatment with curative intent
- •Age >18 years
排除标准
- •Plurimetastiatic disease
- •Palliative intent and re-irradiation treatments
- •Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires
结局指标
主要结局
skeletal muscle strength mass (SMM)
时间窗: before starting hadrontherapy treatment
measurement of sarcopenia to evaluate the development of the affection
次要结局
未报告次要终点
研究者
研究点 (1)
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