Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. We hypothesize that the administration of these two supplements together will be safe in the period surrounding colorectal cancer surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: Green Tea and Milk Thistle Supplements |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
- Number of patients with adverse events or complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01239095
| Contact: Richard L Whelan, MD | (212) 523-8172 | rwhelan@chpnet.org |
| 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 | |
| Principal Investigator: | Richard L Whelan, MD | Mount Sinai St. Luke's Roosevelt Hospital |
More Information
| Responsible Party: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT01239095 History of Changes |
| Other Study ID Numbers: | 10-089 |
| Study First Received: | November 9, 2010 |
| Last Updated: | November 19, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on September 23, 2016