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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01239095
Recruitment Status : Recruiting
First Posted : November 11, 2010
Last Update Posted : February 23, 2021
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Richard Whelan, Feinstein Institute for Medical Research

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Green Tea and Milk Thistle Supplements Phase 1

Detailed Description:
Green tea extract and Silibinin (from the milk thistle plant) have both been shown in experimental studies to have anti-cancer effects as well as limited toxicity. Epigallocatechin-3-gallate (EGCG) is the major active catechin in green tea; it has been shown to prevent and limit tumor growth in murine models1-3. Silymarin, which is extracted from the seeds of the milk thistle plant, is used clinically as a hepatoprotective agent in Europe4. Its major active component, Silibinin, is well-tolerated and largely free of adverse effects5-6. In recent studies, Silibinin has been shown to inhibit the growth of a number of cancers in mouse models, including lung7, bladder8, liver9, prostate10, and colon11-12. Silibinin and EGCG have similar anti-neoplastic mechanisms including: 1) cell cycle arrest via upregulation of P21 and P27 and downregulation of CDK, 2) induction of apoptosis via Caspase-3 activation and cleavage of poly (ADP-ribose) polymerase (PARP), and 3) suppression of angiogenesis and metastasis via inhibition of vascular endothelial growth factor (VEGF) and matrix metalloproteinase (MMP-9)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of patients with adverse events or complications [ Time Frame: 60 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01239095

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Contact: Richard L Whelan, MD (212) 523-8172

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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         
Sponsors and Collaborators
Richard Whelan
St. Luke's-Roosevelt Hospital Center
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Principal Investigator: Richard L Whelan, MD Mount Sinai St. Luke's Roosevelt Hospital
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Responsible Party: Richard Whelan, Professor, Feinstein Institute for Medical Research Identifier: NCT01239095    
Other Study ID Numbers: GCO 17-0002
10-089 ( Other Identifier: St Luke's Roosevelt )
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases