Home » Latest Research » Perioperative anti cancer treatment trial (EGCG and Siliphos Phase 1 Human Study)
Perioperative anti cancer treatment trial (EGCG and Siliphos Phase 1 Human Study)

Alternative and complementary medicine has gained attention in recent years. Within this area of study, the use of molecules and compounds derived from plants has proven beneficial for many disease processes. 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 side effects and toxicity. A major component of green tea is Epigallocatechin-3-gallate (EGCG) which has been shown to prevent and limit tumor growth in small animal studies.17-19 Silymarin, which is extracted from the seeds of the milk thistle plant, is used clinically in Europe to protect the liver. Its major active component, Silibinin, is well tolerated and largely free of adverse effects.20,21 In recent mouse studies, Silibinin has been shown to inhibit the growth of lung, bladder, liver, prostate, and colon cancer.22,23 Silibinin and EGCG have similar anti-cancer mechanisms including:


  • interruption of the cell growth cycle,
  • encouragement of self induced tumor cell death, and
  • suppression of new blood vessel growth.

Last year Dr. Whelan’s lab completed a series of studies in mice that demonstrated that a combination of green tea extract and siliphos (main component is Silibinin), when given for a week before and for 3 weeks after surgery, significantly inhibits the growth of cancer during the month following surgery. It was also determined that this drug combination did not impair or inhibit wound healing (abdominal wall and gastric wound strength was assessed). Thus, this drug combination appears safe for perioperative use. The results of the final study were presented at a national surgical meeting last year and should be published soon.


A Phase 1 human study has just been opened at St. Luke’s Roosevelt Hospital. Consenting patients who are to undergo large bowel resection for cancer will have the opportunity to take these two drugs for the week prior and for 3 weeks after their operation. FDA approval for this study has been obtained. The human investigations research committee (Institutional Review Board) of St. Luke’s Roosevelt Hospital has also approved this study. The goal is to enroll 30-40 patients. More information about the the green tea extract and siliphos follows.


Green Tea Extract:


Green tea has long been celebrated for its health benefits but more recently numerous investigators have discovered that a concentrated form of the most active components of green tea have important anti-cancer effects and have been shown to inhibit tumor growth in animal studies. The green tea extract that will be used in this study is decaffeinated. In regards to side effects related to taking green tea extract, in a previous study of leukemia patients, between 3 and 39 % of patients (taking a dosage similar to that being used in the current study) reported the following side effects; nausea, diarrhea, abdominal pain, anorexia (loss of appetite), indigestion, flatulence (gas), and fatigue. In most cases the symptoms were self-limited and in none of the patients were the symptoms severe enough that the patients stopped taking the green tea pills or dropped out of the study.


In the study to be carried out at St. Luke’s Roosevelt Hospital, commencing 1 week before the surgery date, patients will take 3 green tea extract capsules (250 mg EGCG/capsule) twice daily with food (total EGCG dose per day is 1,500 mg). Drug administration, at the same dose will be resumed when the patient is started on clear liquids after surgery (usually postoperative day 1 or 2) and will be continued until postoperative day 30.


Siliphos:


In regards to the Siliphos pills, at the dose being used for this study no toxicities have been reported in prior human studies. Siliphos contains a concentrated extract of the silybum marianum (milk thistle) plant and is commercially available in 300 mg capsules. The active agent, Silibinin, accounts for 29-36 percent of each capsule (89-109mg per 300 mg capsule). Patients in the study will be instructed to take 3 capsules three times per day (total Silibinin dose of 0.8-0.98 gm daily). Similar to the green tea extract, the Siliphos will be taken for 1 week prior to surgery and, after oral liquids are resumed following surgery, daily until postoperative day 30.


Risks of Entering this Study:


Based on the available information regarding patients who have taken green tea extract and Siliphos the investigators believe that taking these drugs before and after surgery will not increase the rate of complications. However, the reader should note that, because these 2 medications have never been given to patients before large bowel surgery, no one knows for sure if they will have any negative effects. This study will provide that information.


Wound healing is the main area of concern when giving medications before and after surgery. Wound healing complications that can arise after intestinal surgery include; leakage from the rejoining point of the colon or rectum, an abscess in the abdomen, an abdominal wall wound infection, sudden separation of the abdominal wound (called a dehiscence), and hernia formation in the abdominal wall incision. Although infrequent, these complications do occur in a small percentage of patients. As already stated, there is no evidence that either Green Tea extract or Siliphos has any affect on the healing of wounds. The mouse wound healing study, mentioned above; found no difference in healing in mice that were given both these drugs when compared to a group of mice that got no drugs.


To get more Information about this Study:


Patients interested in entering this study should contact Dr. Whelan’s office (212 523 8172).

What Our Patient’s Say…


Our family wishes to express our heartfelt appreciation for the kindness, excellent care and wisdom our mother, Jean Broussard, received during her hospitalization.

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