None listed
Conditions
Interventions
Drug : Participants for clinical trial were randomly assigned to two group, the Experiment group and the Control group, for 3 weeks.
Experiment group: Sipjeondaebotang, 3g/pack, orally administered be
), glucose carbohydrate(49.45%
), caramel pigment(0.5%
) and sipjeondaebo-flavor.
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Fatigue Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactJee Young Lee
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed