Efficacy of Sipjeondaebo-tang for cancer related fatigue: A Placebo- controlled, Randomized, Parallel-grouped study

Kyung Hee University0 个研究点目标入组 50 人开始时间: 待定最近更新: 2020年9月7日

试验速览

暂无简介。

•Adult participants with age 19 or older.
•diagnosed solid tumor confirmed with histological and/or radiological diagnosis. (any type and any stage)
•Completion in cancer-related main treatment (surgery, chemotherapy and radiotherapy) was done not less than 1 month prior to the study enrollment time.
•The participant who had concurrent remnant cancer lesion or the partipant who survived no more than 5 years under no evidence of remnant disease state.
•The Eastern Cooperative Oncology Group (ECOG) performance status = 2
•Continuation of fatigue of 4 or more by the Breif Fatigue Inventory for at least 1 month at study enrollment.
•willingness to participate in the trial and provide written consent

•Experience of pain of 4 point or more by Numeric Rating Scale.
•Pleural effusion, Ascites and peripheral edema of grade 3 or more by Common Terminology Criteria for Adverse Events (CTCAE) grade.
•Anemia with the requirement of transfusion, 7g/dL or under.
•Hypothyroidism diagnosed by clinicans.
•Any psychological disorders and/or malnutrition disorder with requirement of prescribed medication by clinican in current.
•Paralytic or atrophic muscle disorder in current.
•New administration of fatigue-related drug or functional food within 1 week
•Aspartate transaminase or alanine transaminase > 2 * upper normal limit (UNL)
•Creatinine > 1.5 * UNL
•Pregnancy, lactation, or planning a pregnancy during the study period.
•Expected hyper-reaction at the study drug.
•Difficulty complying with the treatment, questionnaire, or study protocol
•Alcoholic or drug abuse
•Planning surgery, chemotherapy and/or radiotherapy overlapped with the study period.

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