Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
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. The researchers hypothesize that
the administration of these two supplements together will be safe in the period surrounding
colorectal cancer surgery.
Phase:
Phase 1
Details
Lead Sponsor:
Richard Whelan St. Luke's-Roosevelt Hospital Center