Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient compliance
研究概览
简要总结
Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. Individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age> 18 years
- •The presence of morphological verification of squamous cell carcinoma of the head and neck
- •No history of anticancer treatment
- •ECOG score 0 - 2
- •Life expectancy is more than 3 months
- •Normal liver, kidney and bone marrow function
- •Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious diseases)
- •Absence of pregnancy, lactation
- •Initial compliance of patients (according to the consultation of a psychologist and questionnaires) with a signed informed consent
排除标准
- •Simultaneous participation in another clinical trial
- •Failure to meet inclusion criteria
- •The patient's condition is ECOG ≥3, Karnovsky ≤40%.
- •Decay / Abscess in the area of tumor lesion
- •Pregnancy or breastfeeding
- •Refractory cachexia
- •Allergy or intolerance to any of the components of ONS
结局指标
主要结局
Patient compliance
时间窗: 1 year
The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.
Quality of life (QoL)
时间窗: 1 year
QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Nutritional status
时间窗: 1 year
Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002
次要结局
- Terms of treatment(during radiation treatment)
- Efficiency of chemoradiation therapy(1 year)
- 1-year locoregional control(1 year)
- 1-year overall survival(1 year)
- Tolerance to chemoradiation therapy - mucositis(4 months)
- Tolerance to chemoradiation therapy - dermatitis(4 months)
- Unplanned breaks(during radiation treatment)
- 1-year relapse-free survival(1 year)
- Dynamics of sensory changes(1 year)
- Dynamics of pain syndrome(1 year)
研究者
Gevorkov Artem R
senior researcher, radiotherapist
National Medical Research Radiological Centre of the Ministry of Health of Russia