Efficacy of Sipjeondaebo-tang for cancer related fatigue

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory

Secondary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer-Quality of life questionnaire;Hospital Anxiety and Depression Scale (HADS);Eastern Cooperative Oncology Group Performance status score (ECOG-PS);blood laboratory test (complete blood count, C-reactive protein, aspartate transaminase (AST) and alanine transaminase (ALT), total Bilirubin, serum Creatinine, serum Potassium & Sodium, cytokine level (natural killer cell, CD3+, CD4+, CD8+, IL-1ß, IL-6, IL-21, TNF-a));compliance and adverse event report;Brief Fatigue Inventory