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临床试验/NCT05613465
NCT05613465招募中不适用

A Double-blind, Randomized Controlled Study of Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo After Radical Surgery

Zhejiang Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Codonopsis pilosula Nnannf

干预措施: Codonopsis (Drug)

Control group

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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