Epigallocatechin gallate (EGCG) for Cancer of Colon

Phase-Based Estimates
1
Effectiveness
1
Safety
UT Health San Antonio, San Antonio, TX
Cancer of Colon+1 More
Epigallocatechin gallate (EGCG) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Colon

Study Summary

This study is evaluating whether a new drug may help prevent cancer from returning in individuals who have had surgery to remove their cancer.

See full description

Eligible Conditions

  • Cancer of Colon
  • Colonic Neoplasms
  • Malignant Neoplasm of Colon

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Epigallocatechin gallate (EGCG) will improve 1 primary outcome in patients with Cancer of Colon. Measurement will happen over the course of 1 year.

1 year
Change in methylation from baseline when compared to the control arm

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
epigallocatechin gallate (EGCG)

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Epigallocatechin Gallate (EGCG) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

epigallocatechin gallate (EGCG)
Drug
Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Green tea leaf
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
S. P.
Sukeshi Patel, Principal Investigator
The University of Texas Health Science Center at San Antonio

Closest Location

UT Health San Antonio - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who have colon or rectal cancer that has been confirmed by a cytological or histological test and who have not received any treatments for cancer are considered to be candidates for the study. show original
People who are 18 years or older. show original
The patient is a candidate for surgery to remove the primary colorectal cancer, and there is no planned chemotherapy beforehand show original
For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception. For men: agreement to use a barrier method of contraception during the treatment period
The person's hematologic, biochemical, and organ function was normal 7 days before the first day of their cycle show original
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 is a measure of how active a person with cancer is show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cancer of colon?

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About 10% of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is related to hereditary factors. More than half of colorectal cancers are related to unhealthy lifestyle. Cigarette smoking is the most important risk factor for colorectal cancer, especially for those who develop cancer before 50 years of age.

Unverified Answer

What are the signs of cancer of colon?

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Symptoms of cancer of colon may first present as a general feeling of not being well. The most common symptoms include change in weight or shape, blood in stool (not always blood), diarrhea, feeling tired, an unexplained fall in temperature, unexplained fatigue or a cough. In children a lump around the mouth, lips or a protruding tongue may occur as the disease progresses. As the cancer progresses, a general feeling of not being well develops with the symptoms becoming more urgent. In time, a constant feeling of fatigue is noted with the cancer affecting the lining of the bowel. Other early signs may be unexplained blood in the sputum, itchiness of the hands or feet, diarrhea, anaemia, blood in the urine and back pain.

Unverified Answer

Can cancer of colon be cured?

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Even if some early lesions are detected early, most of the polyps in stage I will be stable when the patient is in later life. Even if early lesions or those with high-grade dysplasia are found in later life, early and aggressive treatment is indicated.

Unverified Answer

What are common treatments for cancer of colon?

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Only two medications, folic acid and vitamin B12, have been found to be effective in reducing the risk of colorectal cancer in women who have had abnormal results from screening and/or a colonoscopy. Colonoscopy and genetic screening may help women who have not yet developed colorectal cancer choose the best personalized treatment options.

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What is cancer of colon?

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A cancer of colon is a type of colon cancer. Colon cancer is an invasive cancer that most commonly affects colon tissue. When it invades the blood vessels and lymphatic ducts, it is called a 'lymphatic invasion' cancer. The most common type of colon cancer is adenocarcinoma. There are two types of adenocarcinomas: 'distal' (or right colon cancer) and 'proximal' cancers. If you are looking to join a colon cancer clinical trial, [Power(https://www.power.org/clinical-trials/medical-condition/colon-cancer) can help you search recent trials by condition, treatment or location]].

Unverified Answer

How many people get cancer of colon a year in the United States?

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The estimates reported in this study of persons diagnosed with cancer of colon differ substantially from a nationwide population-based study. It is unclear whether the difference is a real effect of the survey design or a reflection of the different demographic characteristics of those eligible for the population-based survey. Given the differences, caution may be prudent in applying population estimates of relative cancer risk estimates to patients treated in specialty practices.

Unverified Answer

What are the latest developments in epigallocatechin gallate (egcg) for therapeutic use?

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EGCG has been the subject of extensive research and clinical development since its discovery by Professor Robert O'Grady at the University of Florida in the 1960s.

Unverified Answer

Has epigallocatechin gallate (egcg) proven to be more effective than a placebo?

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Although the sample was too small to definitively prove this, and the lack of randomisation of the treatment groups, the results are very intriguing. EGCG may be an anti-cancer agent, with better results for colon cancer and possibly worse results for lung cancer of all kinds and esophageal cancer. The use of EGCG could be very helpful in preventing and treating a number of types of cancer but as of the end of October the manufacturer has not made the results available to the scientific community.

Unverified Answer

What is the primary cause of cancer of colon?

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Adenomatous polyps and colonic neoplasia are equally common in patients with chronic [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis). Thus a colonic carcinoma has to be ruled out if a patient or a colonoscopist is found to have ulcerative colitis. Histologically it is difficult to discriminate adenomatous colitis from colonic neoplasia, so careful examination of the colonic mucosa is essential. In addition neoplasia can also occur in the colon in Crohn disease (3-4%), particularly where it has existed for decades (>10 years, for example).

Unverified Answer

Is epigallocatechin gallate (egcg) typically used in combination with any other treatments?

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Results from a recent clinical trial suggest that the reported high prevalence of EGCG use in cancer prevention studies may have been influenced by the existence of bias in study design and/or data extraction, rather than EGCG as a treatment by itself.

Unverified Answer

What is the survival rate for cancer of colon?

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Even the most aggressive therapies may not be cure for colon cancer. The survival rate in our series is similar to that in the literature in the Western society. In our series, there were no differences in survival according to type of surgery and the stage of disease.

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How serious can cancer of colon be?

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For most patients, cancer of colon should be considered as a serious illness. Patients are not well aware of the seriousness of this disease or the treatment options, which are very different. The role of the medical oncologist in this treatment requires clarification and education of the patients, especially the impact of possible cure of the disease.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Cancer of Colon by sharing your contact details with the study coordinator.