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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01239095 |
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Date of registration:
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09/11/2010 |
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Primary sponsor: |
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Public title:
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Oral Green Tea Extract and Milk Thistle Extract to Colorectal Cancer Patients Undergoing Resection
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Scientific title:
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Perioperative Administration of Oral Green Tea Extract/Milk Thistle Extract to Colorectal Cancer Patients Undergoing Colorectal Cancer Resection, a Phase 1 Study |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01239095 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard L Whelan, MD |
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Address:
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Telephone:
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(212) 523-8172 |
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Email:
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rwhelan@chpnet.org |
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Affiliation:
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Name:
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Richard L Whelan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Luke's-Roosevelt Hospital Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colon Cancer
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Intervention(s)
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Dietary Supplement: Green Tea/Milk Thistle Extract
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Primary Outcome(s)
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Number of patients with adverse events or complications
[Time Frame: 60 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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