A Double-blind, Randomized Controlled Study of Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo After Radical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cancer-related fatigue
研究概览
简要总结
Pancreatic carcinoma patients got benefit from adjuvant therapy after radical surgery. Gemcitabine combined with albumin-paclitaxel was recommended as the first-line regimen for adjuvant chemotherapy by NCCN guidelines. The most common non-hematological adverse events associated with gemcitabine combined with albumin-paclitaxel treatment were fatigue (54%), followed by alopecia (50%), and grade 3 or higher adverse events were mainly granulocytopenia, leukopenia, fatigue, and peripheral nerve damage. Cancer-related fatigue (CRF) is the most common concomitant symptom in cancer patients, especially during chemotherapy, which has a negative impact on patients' work, social relationships, emotions and daily activities. Therefore, it is of great clinical significance to improve CRF in cancer patients. From the perspective of traditional Chinese medicine, CRF patients will have a series of syndromes such as low function of viscera, general weakness, and emaciation, which last for more than 2 weeks and affect patients' physiology and psychology at the same time. Codonopsis pilosula Nnannf can restore the postoperative immune ability of patients as soon as possible after chemotherapy.
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, Investigator)
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 pancreatic adenocarcinoma was confirmed by pathology after radical resection.
- •Patients received adjuvant chemotherapy after surgery, and the chemotherapy regimen was gemcitabine combined with albumin paclitaxel.
- •ECOG score was less than
- •The expected survival time was more than 3 months.
排除标准
- •Patients were received radiotherapy, chemotherapy within 4 weeks.
- •Pregnant and lactating women.
- •Patients were known to be allergic to the regimen.
研究组 & 干预措施
intervention
Codonopsis pilosula Nnannf
干预措施: Codonopsis (Drug)
Control group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cancer-related fatigue
时间窗: 9 weeks
The revised Piper fatigue scale (PFS⁃R) was used for accessing Cancer-related fatigue
次要结局
- Immunologic function(9 weeks)
