Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2010 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01239095
First received: November 9, 2010
Last updated: October 20, 2014
Last verified: May 2010
  Purpose

Colorectal cancer is the third most common form of cancer found in the United States. To date surgical resection provides the best chance for cure. Unfortunately, despite "curative" surgery, tumor recurrences develop in 30-40% of patients from either unforeseen residual metastases or from viable tumor cells shed into the circulation before or at the time of surgery. There is evidence from both humans and mice suggesting that tumor growth is stimulated after surgery for a period of time.

This study calls for the administration of a green tea extract and a milk thistle extract, two orally ingested supplements, during the week immediately before and weeks after your surgery. It is not the current standard of care to give anti-cancer drugs during the perioperative period. The basic idea behind this study is that it should be beneficial to inhibit cancer growth in the days leading up to and following surgery. Why is this the case?

It makes sense to limit or inhibit tumor growth before surgery with drugs provided it can be done safely and does not interfere with the surgery. It is also logical to give anti-cancer drugs after surgery because, unfortunately, about 35 percent of colorectal cancer patients, after resection, have hidden tumor cells that remain in the body. There is also strong human evidence that tumor growth is stimulated during the first month after tumor resection as a result of the surgical injuries and the healing process. Therefore, there is good reason to give anti-cancer drugs as soon as possible after surgery in order to offset some of surgery's negative effects.

Although both supplements have been given safely to a wide variety of patients with a number of different medical problems, the two supplements together have never been given to cancer patients during the weeks just before and following surgery. We hypothesize that the administration of these two supplements together will be safe in the period surrounding colorectal cancer surgery.


Condition Intervention Phase
Colon Cancer
Drug: Green Tea and Milk Thistle Supplements
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Number of patients with adverse events or complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green Tea and Milk Thistle Supplements
Patients will receive green tea extract and milk thistle extract supplements for one week prior to surgery and for 30 days after surgery.
Drug: Green Tea and Milk Thistle Supplements
Green Tea Extract: 3,200 mg per day Milk thistle extract with phosphatidylcholine: 2,700 mg per day
Other Names:
  • Green Tea Extract: EGCg
  • Milk Thistle Extract: Siliphos

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239095

Contacts
Contact: Richard L Whelan, MD (212) 523-8172 rwhelan@chpnet.org

Locations
United States, New York
St. Luke's Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Richard Whelan, MD    212-523-8172      
Principal Investigator: Richard L Whelan, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Richard L Whelan, MD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01239095     History of Changes
Other Study ID Numbers: 10-089
Study First Received: November 9, 2010
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014