findmyKOL
Clinical trialNCT01239095TerminatedPhase 1Interventional

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

SponsorRichard WhelanEnrollment23Colon Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mount Sinai St. Luke'S Roosevelt Hospital Center

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Green Tea and Milk Thistle Supplements
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2011
Primary completion
28 Feb 2023
Completion
28 Feb 2023
Last update posted
22 Feb 2023
Registered enrollment
23
Registry id
NCT01239095

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.