NCT06272617招募中不适用
A Single-center, Single-blind Phase II Clinical Trial of Acupuncture for the Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Xerostomia questionnaire scores
研究概览
简要总结
A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
详细描述
The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are:
- the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
- the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
- be treated with real acupuncture or sham acupuncture
- be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.
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
- Triple (Participant, 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 diagnosed with malignant tumors of the head and neck without metastasis
- •Age ≥18, ≤80 years old
- •ZPS score ≤2
- •Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy, including at least one parotid gland
- •Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible
- •Signed informed consent form
排除标准
- •History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth
- •Suspected or confirmed physical closure of both salivary gland ducts
- •Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points
- •Have a history of head and neck radiotherapy
- •Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections
- •Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period
- •Poor oral hygiene or severe periodontitis
- •Poor compliance
- •Other patients who, in the opinion of the investigator, are not suitable for participation in this study
研究组 & 干预措施
treatment group
Experimental
verum acupuncture
干预措施: verum acupuncture (Device)
control group
Sham Comparator
sham acupuncture
干预措施: sham acupuncture (Device)
结局指标
主要结局
Xerostomia questionnaire scores
时间窗: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms
次要结局
- Quality of Life assessed by EORTC QLQ-C30(1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment)
- Changes of oral flora(1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment)
- Taste function assessed by electrogustometer test(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Neck Fibrosis(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Salivary flow rate(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Taste function assessed by patients(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Quality of Life assessed by QLQ-H&N35(1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment)
- Tongue range of motion(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Taste function assessed by taste strips test(1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Oral mucositis(1 week before radiotherapy;twice a week during the treatment(usually every 3 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment)
- Dysphagia(1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment)
- Adverse effects(up to 12 months)
研究者
Xingchen Peng
Professor
West China Hospital
研究点 (1)
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