KCT0002168尚未招募未知
Electro-acupuncture for cancer-related cognitive impairment: a single group, before-after, feasibility study
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •1. Aged equal to or more than 19 to under 75 years
- •2. solid cancer occured in adult age, 6 months after finishing cancer treatment (hormone therapy is allowed)
- •3. Complaint of cognitive impairment with The functional assessment of cancer therapy-cognitive function-perceived cognitive impairments (FACT-cog-PCI score) <63
- •4. Cognitive impairment is suppose to be accompanied with cancer treatment
- •5. Eastern cooperative oncology group (ECOG) performance status 0~2
- •6. agreed with written informed consent
排除标准
- •1. currently receiving any of cognitive rehabilitation therapy, herbal medicine or conventional treatment for cognitive impairment; or having experiences of those treatment within 2 weeks
- •2. history of tumor in central nervous system (CNS), intra-cranial radiotherapy, or intrathecal chemotherapy; or history of CNS diseases which can affect cognitive function
- •3. Recurrence, metastasis or progression of cancer
- •4. history of psycological disorders including alcohol dependence, major depressive disorder, schizophrenia or bipolar disorder
- •5. Korean Vision of Mini-Mental State Exam (K-MMSE) score <20
- •6. score of any field of Hospital anxiety and depression scale (HADS) is equal to or greater than 11
- •7. One or more of belows: Platelet count = 60,000/µL, Hemoglobin < 8g/dL, or absolute neutrophil count < 1,000
- •8. abnormal values of liver function test (LFT) or renal function test (RFT), serious hepatic/renal failure (equal to or more than two times of upper limit of AST or ALT or creatinine = 2.0mg/dL )
- •9. suspected clinically significant inflammation with CRP = 10mg/L and WBC > 10,000/µL
- •10. serum albumin value under normal range and poor oral intake
- •11. seriously unstable medical condition such as abnormal condition demanding medical intervention or management
- •12. life expectancy = 6 months
- •13. planning operation, chemotherapy or radiotherapy during the clinical trial period
- •14. receiving active treatment for anemia (erythropoietin or blood transfusion)
- •15. history of hypersensitivity reaction to acupuncture or electroacupuncture; or difficult to cooperate for the intervention
- •16. inserted prosthesis which is inappropriate for electroacupuncture (pace maker, a heart-lung machine, an electroacrdiograph etc.), or who has possibility of hypersensitivity reaction to electroacupuncture including epilepsy
- •17. currently being enrolled on another clinical trial or it is not passed 4 weeks after completion of previous clinical trial
- •18. pregnant women, lactating women, or planning for pregnancy
- •19. difficult to comply the treatment, visit or reponse to questionnaires etc.
研究者
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