The effect of co-administration of Samryungbaekchulsan to 5 FU + eloxatin on the chemotherapy induced gut toxicity and immune function in colon cancer patient - pilot study
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0001348
- Lead Sponsor
- Daegu Catholic Univercity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. proven colorectal cancer patient
2. age between 18 - 75 yrs
3. Patients who receive FOLFOX(Oxaliplatin/LV5FU2) chemotherapy including Oxaliplatin
4 less than Eastern Cooperative Oncology Group (ECOG) performance status 2
5. patient who is possible to follow up
Exclusion Criteria
1. current metastatic colorectal cancer
2. patients who need surgery including intestinal obstruction
3. prenant, breastfeeding woman
4. patients who have psychological diseases or problems
5. patients who do not agree with the trial
6. moderate to severe hepatotoxicity or renal toxicity(AST, ALT > 100 IU/L, Creatinine >3.4mg/dl)
7. allergic or hyper-reactive response to Samryungbaekchulsan
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gut toxicity in CTCAE(Common Terminology Criteria for Adverse Effect) grading system
- Secondary Outcome Measures
Name Time Method immunologic function including WBC(White Blood Cell) count, CRP(C-Reactive Protein), T-cell, immunoglobulin G,A,M, NK(Natural Killer) cell, complement