KCT0002170招募中未知
Moxibustion for treating cancer-related fatigue: a multicenter, assessor-blinded, randomized controlled clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 96
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 79(Year)（—）
- 性别
- All
入选标准
- •1. Both male and female, aged 19 or over, but under 80 years
- •2. Cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy, immunotherapy, except for on-going hormone therapy, which must have been initiated at least 3 weeks prior to enrollment) at least 12 weeks before the trial
- •3. Continuous fatigue related to cancer treatment or cancer itself for at least 4 weeks, fulfilment of The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic criteria for cancer-related fatigue, and 4 and higher points in a Brief Fatigue Inventory (BFI) score
- •4. The Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •5. Willingness to participate in the trial and provide written consent
排除标准
- •1. Current level of fatigue even before the diagnosis of cancer
- •2. Severe anemia (platelet count < 60,000/µL, or hemoglobin < 8 g/dL, or absolute neutrophil count < 1,000)
- •3. Receiving aggressive treatment for anemia (e.g. erythropoietin or blood transfusion)
- •4. Poor oral intake with a lower-than-normal level of serum albumin
- •5. Any significant sign or symptom of inflammation with C-reactive protein = 10 mg/L and white blood cell > 10,000/µL
- •6. Abnormal findings in thyroid function test (abnormal level of Free thyroxine [free T4] and thyroid stimulating hormone [TSH] < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
- •7. Abnormal findings in liver function test or renal function test, or serious liver failure or renal failure
- •(aspartate aminotransferase or alanine aminotransferase = 2 x upper normal range, or creatinine = 2.0 mg/dL)
- •8. A score of 11 points and over in subscale of anxiety or depression in Hospital Anxiety and Depression Scale (HADS)
- •9. A score of 15 points and over in insomnia severity index (ISI)
- •10. Level of cancer pain measured by numeric rating scale = 4
- •11. Six months or less life expectancy
- •12. A plan of surgery, chemotherapy, radiotherapy during the study
- •13. Past history of medication (methylphenidate, modafinil, bupropion, dexamethasone) to manage cancer-related fatigue at least 4 weeks before the trial
- •14. Past history of Korean medical treatment (e.g. acupuncture, moxibustion, cupping, or herbal medicine, etc.) to manage cancer-related fatigue at least 4 weeks before the trial
- •15. Past history in the preivous 4 weeks or a new plan during the study of initiating dietary supplements or non-pharmacologic therapies (e.g. cognitive behavioral therapy, exercise etc.) to alleviate cancer-related fatigue
- •16. Having participated in other clinical trial in the precious 4 weeks
- •17. Past history of hypersensitivity reactions or serious adverse reactions after moxibustion treatment or an inability to cooperate with moxibustion treatment due to some reasons such as dyspnea
- •18. Women who are pregnant, lactating, or planning to become pregnant
- •19. Presence of other apparent factors or any diseases that could cause the current fatigue other than cancer treatment or cancer itself
研究者
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