A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Radiation-induced xerostomia
研究概览
简要总结
This study is a single-center, double-blind, randomized controlled clinical trial with placebo as the control, aiming to evaluate the effectiveness of spermidine in preventing radiation-induced xerostomia during radiotherapy for head and neck tumors (including nasopharyngeal carcinoma).
详细描述
This study is a single-center, double-blind, randomized controlled clinical trial with placebo as the control, aiming to evaluate the effectiveness of spermidine in preventing radiation-induced xerostomia during radiotherapy for head and neck tumors (including nasopharyngeal carcinoma).
The experimental group took spermidine capsules twice a day with meals, while the placebo group took placebo capsules twice a day with meals. The appearance and taste of the placebo and spermidine were kept the same.
The primary end point was radiation-induced xerostomia, as determined by the Xerostomia Questionnaire in which a higher score indicates worse radiation-induced xerostomia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
- •Aged ≥18 years and ≤80 years.
- •ECOG performance status score ≤
- •Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose >50 Gy, where: Both parotid glands receive an average dose ≥25 Gy; or one gland receives a dose ≥25 Gy and the other receives any dose.
- •Blood routine parameters: hemoglobin ≥100 g/L, platelets ≥80×10⁹/L, white blood cell count ≥3.0×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L.
- •Signed informed consent form.
排除标准
- •History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.
- •Wheat allergy or gluten intolerance.
- •Suspected or confirmed physical occlusion of bilateral salivary gland ducts.
- •Prior history of head and neck radiotherapy.
- •Use of any medications or herbal supplements that may affect salivary function within the past 30 days, or planned/final use during the study period (e.g., amifostine, cholinergic agonists [pilocarpine, cevimeline], certain β-adrenergic antagonists, anticholinergic drugs, or other known salivary function modifiers). If using saliva substitutes, patients must abstain from use for at least 24 hours prior to saliva and questionnaire data collection.
- •Poor oral hygiene or severe periodontitis.
- •Poor compliance.
- •Pregnant or breastfeeding.
- •Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional/psychiatric disorders).
研究组 & 干预措施
Treatment Cohort
One week before the initiation of radiotherapy or concurrent chemoradiotherapy, in addition to routine health education, nursing care, and treatment, participants will start taking spermidine capsules twice daily with meals, continuing until one week after the completion of radiotherapy.
干预措施: Spermidine (Drug)
Control Cohort
One week before the initiation of radiotherapy or concurrent chemoradiotherapy, in addition to routine health education, nursing care, and treatment, participants will start taking placebo capsules twice daily with meals, continuing until one week after the completion of radiotherapy.
干预措施: Spermidine simulants (Drug)
结局指标
主要结局
Radiation-induced xerostomia
时间窗: Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.
The primary end point was radiation-induced xerostomia, as determined by the Xerostomia Questionnaire in which a higher score indicates worse radiation-induced xerostomia .
次要结局
- Unstimulated salivary flow rate(Radiation-induced xerostomia will be assessed weekly from the start of radiotherapy to 3 months after its completion, totaling approximately 18-19 weeks.)
- Quality of life (EORTC QLQ-C30)(1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.)
- Quality of life (EORTC QLQ-H&N35)(1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital