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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
Not Enrolling
Both
Colon Cancer

Thank you

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 CenterNew York, New York  10019