A Prospective Single-arm Cohort Study on the Effect of Peri-radiotherapy Nutrition Management on Radiation-induced Oral Mucositis in Patients With Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Degree of radiation-induced oral mucositis (RTOG criteria)
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . The main questions it aims to answer are:
- [question 1]Whether whole-course nutritional intervention can improve radiation-induced oral mucositis in patients with HNC.
- [question 2]Whether whole-course nutritional intervention can improve nutritional status and inflammation.
Participants will be treated according to the NCCN guidelines. In addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group.
Researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years old
- •Advanced head and neck cancer (III-IV inoperable) is clearly diagnosed
- •Predicted survival time > 3 months
- •Radical radiotherapy combined with chemotherapy or immunotherapy was performed in our hospital
- •The patient has clear consciousness and no communication disorder
- •Informed consent and voluntary participation in this study
排除标准
- •Patients with previous surgery or radiotherapy for head and neck cancer
- •Patients with concurrent or previous history of other tumors
- •Distant metastasis
- •Patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition
- •Severe renal insufficiency (eGFR<30ml/min/1.73m2)
- •Combined with poorly controlled metabolic diseases such as diabetes
- •Doctors or researchers deem that they are not suitable to participate in the study.
研究组 & 干预措施
Peri-radiotherapy nutrition management group
Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time.
干预措施: nutrition management (Behavioral)
结局指标
主要结局
Degree of radiation-induced oral mucositis (RTOG criteria)
时间窗: six months
The Radiation Oncology Group (RTOG) grade of acute radiation injury was used for evaluation, which was divided into 0 to Ⅳ grades. The mild grade included 0, Ⅰ, and Ⅱgrades (grade 0 was no mucosal response; GradeⅠ: erythema, mild pain; GradeⅡ: spotty mucositis with serous exudation), severe grade Ⅲ- IV (Ⅲ: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage).
次要结局
未报告次要终点
研究者
Jing Yan
Chief Physician/Deputy Administrative Director of Oncology Department, Nanjing Drum Tower Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School