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

NCT01239095 | Terminated Phase 1 FDA Drug

• 2 other identifiers: GCO 17-000210-089
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events or complications

  60 days

Study Arms (1)

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.

Drug: Green Tea and Milk Thistle Supplements

Interventions

Green Tea and Milk Thistle Supplements DRUG

Green Tea Extract: 3,200 mg per day Milk thistle extract with phosphatidylcholine: 2,700 mg per day

Also known as: Green Tea Extract: EGCg, Milk Thistle Extract: Siliphos

Green Tea and Milk Thistle Supplements

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard Whelan: lead
• St. Luke's-Roosevelt Hospital Center: collaborator

Study Sites (1)

Mount Sinai St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Tea

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Richard L Whelan, MD

  Mount Sinai St. Luke's Roosevelt Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 11, 2010
• Study Start: July 1, 2011
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)