ITMCTR2024000177已完成1 期
Clinical study of transcutaneous electrical stimulation of acupoints combined with intradermal needling for the prevention of acute moderate to severe radiation pneumonitis
Tianjin Cancer Hospital Airport Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •(1) Age range: male and female patients between the ages of 18 and 80 years old who are ready to receive radiation therapy and meet the clinical diagnostic criteria for lung cancer;
- •(2) Functional status score: patients need to have a Karnofsky Performance Status (KPS) score of 70 or more, indicating that the patient has a good ability to perform daily activities to live a better self-care;
- •(3) Survival expectancy: based on the physician's assessment, the patient's expected survival needs to be at least 6 months to ensure that there is sufficient time to evaluate the treatment effect;
- •(4) Dose of radiotherapy: The radiotherapy plan that the patient will receive should have a single irradiation dose range of DT1.5 to 3.0 Gy/day to lung tissue and a total dose between 45 Gy and 60 Gy;
- •(4) Informed consent: patients must be willing and able to comply with the trial requirements, including signing an informed consent form indicating an understanding of the purpose, procedures, and possible risks and benefits of the trial, which ensures the ethical and compliant nature of the study;
- •(5) Other clinical trials: participants were not involved in any other clinical trials prior to the start of this trial to avoid interfering with the accuracy of the results;
- •(6) Ensuring the absence of major complications: the patient has no major complications such as severe heart disease, kidney disease or liver disease to minimize potential risks during treatment;
- •(7) Specific lung cancer type and stage: all types of lung cancer with a clear diagnosis, without limiting the types of lung cancer (e.g. non-small cell lung cancer, small cell lung cancer) and their clinical stages.
排除标准
- •Exclusion criteria
- •(1) Allergic exclusion: this includes those with known allergies to any materials used in the study, such as electrode pads and intradermal needles;
- •(2) Prior treatment history: patients with a history of regional radiotherapy to the chest are excluded to prevent prior treatment from influencing the results of this study;
- •(3) Serious comorbidities: patients with significant organ dysfunction such as pulmonary, cardiac, hepatic or renal dysfunction or with severe infections;
- •(4) Contraindications to radiotherapy: the presence of acute infections, pregnancy, interstitial pneumonia or immunologic pneumonia, severe mental illness and other contraindications to radiotherapy;
- •(5) Inability (refusal) to participate in follow-up visits;
- •(6) Patients with low compliance and non-adherence to the trial protocol.
研究者
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