Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
Primary Purpose
Colon Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Green Tea and Milk Thistle Supplements
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer
Eligibility 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
Sites / Locations
- Mount Sinai St. Luke's Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Green Tea and Milk Thistle Supplements
Arm Description
Patients will receive green tea extract and milk thistle extract supplements for one week prior to surgery and for 30 days after surgery.
Outcomes
Primary Outcome Measures
Number of patients with adverse events or complications
Secondary Outcome Measures
Full Information
NCT ID
NCT01239095
First Posted
November 9, 2010
Last Updated
February 21, 2023
Sponsor
Richard Whelan
Collaborators
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT01239095
Brief Title
Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
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 Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Whelan
Collaborators
St. Luke's-Roosevelt Hospital Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Green Tea and Milk Thistle Supplements
Arm Type
Experimental
Arm Description
Patients will receive green tea extract and milk thistle extract supplements for one week prior to surgery and for 30 days after surgery.
Intervention Type
Drug
Intervention Name(s)
Green Tea and Milk Thistle Supplements
Other Intervention Name(s)
Green Tea Extract: EGCg, Milk Thistle Extract: Siliphos
Intervention Description
Green Tea Extract: 3,200 mg per day Milk thistle extract with phosphatidylcholine: 2,700 mg per day
Primary Outcome Measure Information:
Title
Number of patients with adverse events or complications
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Whelan, MD
Organizational Affiliation
Mount Sinai St. Luke's Roosevelt Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
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