Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Median time for the occurrence of Grade 2 radiation-induced oral mucositis
研究概览
简要总结
The goal of this study is to compare glutamine combined with thalidomide with glutamine in preventing radiation-induced oral mucositis. The aim of this study is to answer whether glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.
详细描述
Explore the therapeutic efficacy of glutamine combined with Thalidomide as compared to glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old;
- •Patients with locoregional advanced squamous cell carcinoma confirmed by pathological histology or cytology and requiring radiotherapy or concurrent chemoradiotherapy;
- •Patients who have received more than 45Gy of radiation in the oral area;
- •ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1;
- •Basic hematological indicators are normal: White blood cell count ≥ 4×10^9/L; Absolute neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 90 g/L;
- •Basic renal function is normal: Serum creatinine ≤ 1.5×ULN (Upper Limit of Normal) or Creatinine Clearance Rate (CrCl) > 60 mL/min (using the Cockcroft-Gault formula):
- •For women: CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl) For men: CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl)
- •Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN.
- •Signed written informed consent.
排除标准
- •Participated in another interventional clinical trial within the last 30 days;
- •Patients with severe underlying oral diseases who cannot tolerate radiation therapy;
- •Patients allergic to glutamine and thalidomide;
- •Patients receiving secondary radiation therapy to the oral area;
- •Pregnant women (confirmed by blood or urine HCG testing) or breastfeeding women, or participants of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female participants) until at least 6 months after the last trial treatment;
- •Patients with underlying peripheral neuropathy;
- •Individuals deemed by the researcher to be inappropriate for participation in this study;
- •Unwilling to participate in this study or unable to sign informed consent.
研究组 & 干预措施
glutamine alone
glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.
干预措施: glutamine alone (Drug)
glutamine combined with thalidomide
glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.
Thalidomide: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take orally at 100mg, once every evening.
干预措施: glutamine combined with thalidomide (Drug)
结局指标
主要结局
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
时间窗: during radiotherapy up to 4 weeks
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
次要结局
- Body mass index(during radiotherapy up to 4 weeks)
- incidence rate of ≥grade 2 oral mucositis(during radiotherapy up to 4 weeks)
- QOL(during radiotherapy up to 4 weeks)
- adverse effects(during radiotherapy up to 4 weeks)
- incidence rate of ≥grade 3 oral mucositis(during radiotherapy up to 4 weeks)
研究者
Mei Shi
clinical professor of department of radiation oncology of XiJing hospital
Air Force Military Medical University, China