Efficacy and Safety of Bojungikgi-tang for Anorexia in Patients with Colorectal Cancer after Curative Resection and Chemotherapy : A single-arm, Open label, Single cencer Trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004785
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 20
1. Adults aged = 19 years
2. Subjects who have been confirmed histologically for rectal or colon cancer and completed curative resection and chemotherapy and no further chemotherapy
3. Subjects able to intake medicine orally
4. Eastern Cooperative Oncology Group (ECOG) performance status score = 2
5. Subjects who are suffering from anorexia after curative resection and chemotherapy, and score on the Visual Analog Scale (VAS) for anorexia = 40/100?mm (100mm is the worst anorexia score)
6. Subjects who are not taking megestrol acetate for stimulating appetite
7. After hearing and fully understanding the detailed description of the clinical trial, Subjects who provide written informed consent for voluntary participation in the trial and observing the precautions
8. Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires.
9. Subjects who can follow up during the clinical trial
10. Subjects who have life expectancy of 3 months or more
1. Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis, have other malignancies or with a history of other malignancies within 5 years at the screening visit(Except cured basal or squamous cell skin cancer, cervical epithelial cancer, thyroid cancer, prostate cancer or breast cancer (Cured basal or squamous cell skin cancer, cervical epithelial cancer, thyroid cancer, prostate cancer and breast cancer excluded)
2. Total bilirubin level higher than 2.0?/dL
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal
4. Creatinine level higher than 1.5 times the upper limit for normal
5. Subjects who complain of uncontrolled pain = NRS(Numeral Rating Scale) 5 despite the use of analgesics
6. Subjects who have uncontrolled hypertension(Diastolic blood pressure>100mmHg or systolic blood pressure>160mmHg), diabetes, active infection or heart diseases such as symptomatic congestive heart failure or unstable angina
7. Subjects who took other herbal medicine or other medicines that is used for the same therapeutic purpose of trial medicine or can affect the improvement of anorexia(e.g. corticosteroids, cyproheptadine) or health functional food, food and medical supplies containing main base materials even if it’s not used for the same therapeutic purpose, within 2 weeks at the screening visit
8. Subjects with uncontrolled pleural effusion, ascites, pericardial effusion
9. Subjects who have a major psychotic disorder diagnosed by DSM-? that is taking or should be taking psychiatry medications(except insomnia)
10. Subjects who have alcoholism or drug dependence
11. Subjects with a history of serious drug allergies or who have hypersensitivity to the Investigational Product(the main ingredient and its components)
12. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
13. Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception
14. Subjects who have participated in other clinical trials within 6 months (180 days prior to screening visit) or plan to participate in other clinical trials during the trial
15. Subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator
16. Subjects who are or must have parenteral or tube nutrition
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Changes of Anorexia/cachexia subscale(A/CS) of Functional Assessment of Anorexia/Cachexia Therapy(FAACT)
- Secondary Outcome Measures
Name Time Method The Changes of FACT-G score of Functional Assessment of Anorexia/Cachexia Therapy(FAACT);The Changes of Colorectal cancer subscale of FACT-C(Functional Assessment of Cancer Therapy For patients with Colorectal cancer);The Changes in Visual Analogue Scale (VAS) of Anorexia;The Change of High sensitivity C-Reactive Protein(hsCRP) in Blood;The Changes of Body weight, Body Mass Index(BMI), Skeletal muscle mass(kg);The Changes of Na, K, Cl, BUN, Creatinine;The Change of CD4/CD8;Adverse effect;abnormal findings according to vital sign;abnormal findings according to physical examination;abnormal findings in clinical laboratory test;abnormal findings in chest X-ray