Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
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.
|Study Design:||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|
- Number of patients with adverse events or complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239095
|Contact: Richard L Whelan, MD||(212) email@example.com|
|United States, New York|
|Mount Sinai 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|
|Principal Investigator:||Richard L Whelan, MD||Mount Sinai St. Luke's Roosevelt Hospital|