研究疾病:
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癌因性疲乏
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研究疾病代码:
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Target disease:
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cancer-related fatigue
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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单病例随机对照研究
N of 1 Trial
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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主要目的:通过多中心随机对照研究探讨益肺散结方对非小细胞肺癌患者化疗相关癌因性疲乏的有效性和安全性。
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Objectives of Study:
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Main purpose: To explore the efficacy and safety of Yifei Sanjie Recipe for chemotherapy-related cancer-related fatigue in patients with non-small cell lung cancer.
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药物成份或治疗方案详述:
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所有患者均接受含铂双药的化疗方案,可以联合抗血管生成药物,如贝伐珠单抗;免疫检查点抑制剂,如PD-1单抗或PD-L1单抗。
1、益肺散结方 根据“益气除痰方”拟方,由西洋参、浙贝母、法半夏等混合而成。用法:口服,一次1袋,一日1次。
2、安慰剂 拟采用糊精、焦糖等比例调和,并添加1-5%益肺散结方提取液混合而成与益肺散结方等比例颗粒剂。用法为口服,一次1袋,一日1次。
每两个疗程中益肺散结方和安慰剂配对使用。每个患者在治疗的过程中均有机会接受益肺散结方和安慰剂的治疗。
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Description for medicine or protocol of treatment in detail:
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Basic treatment: platinum-containing dual-drug chemotherapy,for 4-cycle. It can be combined with anti-angiogenic drugs, such as bevacizumab, immune checkpoint inhibitors, such as PD-1 antibody, or PD-L1 antibody.
Treatment group: Basic treatment combined with Yifei Sanjie Recipe.Yifei Sanjie Wan (8-gram per bag) is made up of radix ranunculi ternati, bombyx batryticatus, sarcandra glabra, pleione bulbocodioides, fritillary bulb, rhizome, ganoderma lucidum and american ginseng. Yifei Sanjie Recipe, one bag each time, two times a day, boiled water, oral, continuous use, 14 days per course of treatment beginning with the first day of chemotherapy.
Control group: basic treatment combined with placebo (simulation of Yifei Sanjie Recipe), using the same method as the experimental group.
Yifei Sanjie Recipe paired with placebo in every two courses of treatment. Thus, every patient has the opportunity to receive Yifei Sanjie Recipe and placebo during the treatment equally.
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纳入标准:
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1.经病理或细胞学诊断的非小细胞肺癌患者;
2.符合癌因性疲乏的诊断标准;
3.估计生存期超过3个月,PS≤2,年龄18~80岁;
4.不适合使用靶向药物治疗的患者;
5.根据指南,患者需接受含铂的双药为基础的化疗方案,包括AP(培美曲塞+顺铂/卡铂)、TP(紫杉醇+顺铂/卡铂)DP(多西他赛+顺铂/卡铂)、GP(吉西他滨+顺铂/卡铂);可联合抗血管药物和免疫检查点抑制剂;
6.自愿接受本方案治疗、能按医嘱坚持复诊且依从性良好者。
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Inclusion criteria
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1. Patients with non-small cell lung cancer diagnosed by pathology or cytology;
2. Meet the diagnostic criteria for cancer-related fatigue;
3. The estimated survival time is more than 3 months, PS<=2, aged 18 to 80 years;
4. Patients who are not suitable for targeted drug therapy;
5. According to the guidelines, patients need to receive platinum-containing dual-drug-based chemotherapy, including AP (pemetrexed + cisplatin/carboplatin), TP (paclitaxel + cisplatin/carboplatin), DP (docetaxel) + Cisplatin/carboplatin), GP (gemcitabine + cisplatin/carboplatin); can be combined with anti-vascular drugs and immune checkpoint inhibitors;
6. Those who voluntarily accept the treatment of this program, can adhere to the follow-up visit as prescribed by the doctor and have good compliance.
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排除标准:
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1.任何可能阻碍受试者完成临床试验过程的情况,包括但不限于严重、难以控制的器质性病变或感染,不稳定心绞痛、充血性心力衰竭等;甲状腺功能低下尚未控制者;
2.严重肝肾功能异常者(血肌酐≥1.5倍ULN;ALT或AST≥5倍ULN;胆红素≥1.5倍ULN);
3.伴有症状的、不易控制的神经、精神障碍患者,及其他不能独立或者在他人协助完成问卷调查者。
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Exclusion criteria:
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1. Any situation that may hinder the subject from completing the clinical trial process, including but not limited to serious, difficult to control organic disease or infection, unstable angina, congestive heart failure, etc.; hypothyroidism has not been controlled;
2. Severe liver and kidney dysfunction (serum creatinine >= 1.5 ULN; ALT or AST >= 5 ULN; bilirubin >= 1.5 ULN);
3. Patients with neurological or mental disorders who are symptomatic and difficult to control, and others who cannot complete the questionnaire independently or assist by others.
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研究实施时间:
Study execute time:
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从From
2020-01-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2021-07-01
至To
2022-11-01
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