NCT05834712已完成不适用
A Randomized, Controlled, Phase II Clinical Study on the Improvement of Malnutrition in Patients with Stage III-IVa Nasopharyngeal Carcinoma with or Without the Use of Mobile Medical Platform Full-course Nutritional Intervention
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2022年5月11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
- 224
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Voluntarily participate and sign the informed consent in writing.
- •2.Stage III-IVa (AJCC 8th edition staging) .
- •3.Received induction chemotherapy + concurrent chemoradiotherapy .
- •4.18-70 years old.
- •5.Pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III).
- •6.No previous anti-tumor therapy .
- •7.ECOG score 0-
- •8.Ensure contraception during the study period.
- •9.Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
- •Liver function: ALT, AST < 2.5 times the upper limit of normal (ULN), total bilirubin < 2.0 × ULN.
- •Renal function: serum creatinine <1.5×ULN.
- •12.Able and willing to use a mobile phone or tablet to fill in the electronic scale.
排除标准
- •1.Received antitumor therapy in the past.
- •The pathology was keratinizing squamous cell carcinoma (WHO type I).
- •3.Pregnant women who are in the reproductive period and have not taken effective contraceptive measures.
- •Has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
- •5.Patients with significantly low heart, liver, lung, kidney and bone marrow functions.
- •6.Serious, uncontrolled medical diseases and infections.
- •7.Concurrent use of other experimental drugs or other clinical trials.
- •Refused or unable to sign the informed consent to participate in the trial.
- •9.Those who have other contraindications to treatment.
- •10.Persons with personality or mental disorders, no capacity for civil conduct or limited capacity for civil conduct.
结局指标
主要结局
weight loss
时间窗: 1 month after chemoradiotherapy
Differences in the proportion of patients who lost \>10% of their body weight at 1 month after chemoradiotherapy between experimental and control groups
次要结局
- weight loss >10%(at the end of chemoradiotherapy)
- weight loss >20%(at the end of chemoradiotherapy)
- ncidence rate of adverse events (AEs)(at the end of chemoradiotherapy)
- change of PG-SGA(1 month after chemoradiotherapy)
- change of NRS2002(1 month after chemoradiotherapy)
研究者
Hai-Qiang Mai,MD,PhD
professor
Sun Yat-sen University
研究点 (1)
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