Effect of Yukgunja-tang for Anorexia in Cancer Patients
- Conditions
- Neoplasms
- Registration Number
- KCT0002847
- Lead Sponsor
- Dunsan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
1) patients who have a histologically or cytologically confirmed solid tumour; individuals who are suffering from anorexia
2) men and women aged 20-80 years who can write and understand
3) Visual analog scale(VAS) for anorexia = 40/100 mm
5) neutrophils =1500/µL, platelets =100,000/µL
6) total bilirubin of the maximum normal level or less (1.2 mg/dL)
7) alanine aminotransferase(ALT), aspartate aminotransferase(AST) lower than 2-fold the upper limit of normal (35/45U/l)
8) creatinine lower than 1.5 fold the upper limit of normal (1.09 mg/dL)
9) written informed consent for participation in the trial
1) impossible to intake orally
2) Patients who are undergoing chemotherapy or less than one month after completion of chemotherapy
3) survived at least 5 years after cancer diagnosis (with no additional cancer diagnosis)
4) Eastern Cooperative Oncology Group (ECOG) performance status score = 3
5) Patients who have dementia, delirium or depression
6) reports more than 7 points of Numeric Pain Rating Scale in 2 weeks of screening
7) Patients who have diseases like hypoadrenalism which can influence on appetite
8) Patients who are taking appetite stimulants such as megestrol acetate, corticosteroids and thalidomide
9) Women of childbearing potential
10) others who are judged not to be appropriate to study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes in the anorexia/ cachexia subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT);cost per QALY(Quality Adjusted Life Years) gained
- Secondary Outcome Measures
Name Time Method The changes in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score (except Anorexia cachexia subscale);Cost per visual analog scale(VAS);Visual analog scale(VAS) for anoreixa;weight and body mass index(BMI);Leptin;Tumor necrosis factor a (TNF-a);Ghrelin;Interleukin-6(IL-6)