Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
GCO 17-0002
- SECONDARY ID:
10-089
- NCT ID:
NCT01239095
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Green Tea and Milk Thistle Supplements | Green Tea Extract: EGCg, Milk Thistle Extract: Siliphos | Green Tea and Milk Thistle Supplements |
Purpose
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)
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Green Tea and Milk Thistle Supplements | Experimental | Patients will receive green tea extract and milk thistle extract supplements for one week prior to surgery and for 30 days after surgery. | - Green Tea and Milk Thistle Supplements
|
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
| Maximum Eligible Age: | 85 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of patients with adverse events or complications |
| Time Frame: | 60 days |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Richard Whelan |
Last Updated
February 23, 2021
