NCT06472739招募中2 期
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2023年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The incidence of severe oral mucositis(grade 3+)
研究概览
简要总结
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.
详细描述
Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, world health organization [WHO] II or III).
- •b. Original clinical staged as II-IVa (according to the 8 th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-65 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- •i. With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine< 1.5×ULN.
- •j. The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to
- •k. Patients must be informed of the investigational nature of this study and give written informed consent.
- •l. Patients receive induction chemotherapy plus concurrent chemoradiotherpy or concurrent chemoradiotherapy, or radiotherapy alone.
排除标准
- •Age <18 or >65years. c. With clinical stage of I or IVb (according to the 8 th AJCC edition). d. Patients with tumor recurrence or distant metastasis. e. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •f. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •g. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •h. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •i. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and mental disturbance.
研究组 & 干预措施
GM-CSF group
Experimental
Patients use GM-CSF mouthwash four times per day during radiotherpay.
干预措施: GM-CSF (Drug)
结局指标
主要结局
The incidence of severe oral mucositis(grade 3+)
时间窗: During radiotherapy, up to 1.5 months.
To evaluate the incidence of severe oral mucositis between the two arms.
次要结局
- Acute toxicities(One month.)
- The last time of ≥3 grade oral mucositis(1 months after radiotherapy)
- Daily questionaire of oral mucositis (OMDQ)(1 months after radiotherapy)
- Quality of life(QOL)(1 months after radiotherapy)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University
研究点 (1)
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