Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study
Phase 1
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Colon Cancer
Both
Colon Cancer
Trial Information
Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study
Inclusion Criteria:
- Patients must be age 18 to 85 years
- Patient must have biopsy proven colon or rectal cancer
- Cancer should be judged to be stage 1 to 3 based on preoperative staging
- Patients may be any race and any gender
Exclusion Criteria:
- Patients with cancer judged to be stage 4 are not eligible
- Patients undergoing emergency surgery for cancer are not eligible
- Patients who are immunosuppressed or taking immunosuppressive medications (steroids
or chemotherapeutic agents) are not eligible
- Patients with Crohn's disease or ulcerative colitis are not eligible
- Patients with other malignancies are not eligible
- Patients who are taking part in other neoadjuvant and early adjuvant chemotherapy
trials are not eligible
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients with adverse events or complications
Outcome Time Frame:
60 days
Safety Issue:
Yes
Principal Investigator
Richard L Whelan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Luke's-Roosevelt Hospital Center
Authority:
United States: Food and Drug Administration
Study ID:
10-089
NCT ID:
NCT01239095
Start Date:
July 2011
Completion Date:
July 2012
Related Keywords:
- Colon Cancer
- Colonic Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| St. Luke's Roosevelt Hospital Center | New York, New York 10019 |
