Effects Of Manual Acupuncture On Mucositis Due To Radiotherapy For Nasopharynx Cancer On Visual Analogue Scale (Vas) Score And Quality Of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35)
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. The main questions it aims to answer are:
- Do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (VAS) in patients with oral mucositis compared with sham manual acupuncture and medication?
Participants will receive acupuncture therapy 2 times a week for 3 weeks
详细描述
This is a clinical trial study to evaluate the role of acupuncture in pain relief and improving the quality of life of nasopharyngeal cancer patients with post-radiotherapy mucositis. Participants were 30 men/females with mucositis in post-radiotherapy nasopharyngeal cancer aged 19-59 years. They will be divided into 2 groups: (1) verum acupuncture and (2) sham acupuncture. Acupuncture is scheduled 2 times per week for 3 weeks. Research assessment on pain scale and improvement in quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have been proven by anatomical pathology examination to have a diagnosis of Nasopharyngeal Cancer.
- •Subjects with adult Nasopharyngeal Cancer aged 19 years - 59 years.
- •Nasopharyngeal Cancer Patients, who underwent bilateral Head and Neck radiotherapy.
- •Patients diagnosed with mucositis.
- •Willing to participate in the research until completion by signing an informed consent.
排除标准
- •Nasopharyngeal Cancer patients who have distant metastases (based on the Tumor Node Metastasis (TNM) classification with the presence of metastases (M1)).
- •Subjects who still smoke and consume alcohol to date.
- •Patients have contraindications for manual acupuncture, namely the use of anti-coagulant drugs, the presence of infection or wounds at the puncture site, emergency conditions, and pregnancy.
- •There is a history of allergy to stainless steel materials.
- •Patients with blood clotting disorders; Platelets <50,000/μL, Absolute Neutrophil Count (ANC) <1000/mm3, patients undergoing anticoagulant therapy with International Normalized Ratio (INR) >2.47
结局指标
主要结局
European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35)
时间窗: Monitored before and after intervention. After the intervention; Results will be measured at week 3 after intervention and results will be measured at week 4 without intervention.
The EORTC QLQ-H\&N35 is a questionnaire designed to assess the health-related quality of life in patients with head and neck cancer. It consists of 35 questions covering various aspects such as pain, swallowing, speech, social eating, and emotional functioning. Each question is scored on a scale from 1 to 4, with 1 representing "not at all" and 4 representing "very much". To calculate a score for each domain, the individual item scores are averaged. Higher scores indicate more severe symptoms or poorer quality of life in that domain. Additionally, there are specific guidelines provided by the European Organization for Research and Treatment of Cancer (EORTC) for scoring and interpreting the results, with a minimum and maximum scale of 0-33: mild, 34-66: moderate, 67-100: severe.
Visual Analogue Scale
时间窗: Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.
VAS is used to assess pain complaints on a scale of 1-10. The VAS scale consists of: mild pain scale 1-3, moderate pain scale 4-6 and severe pain scale 7-10
次要结局
未报告次要终点
研究者
Imelda Dimara
Medical Doctor
Indonesia University