Study on Using Curcumin to Improve Cancer-Free Survival After Prostate Surgery
Sponsor: yair lotan
ClinicalTrials ID:NCT02064673
This clinical trial is exploring whether taking curcumin, a natural supplement, can help prevent the return of prostate cancer in patients who have had surgery to remove the prostate.
Patient Parameters
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Program Overview
The purpose of this study is to find out if taking curcumin, a natural supplement, can help prevent prostate cancer from coming back in patients who have had their prostate removed. The study will compare the effects of curcumin to a placebo (a pill with no active ingredient) to see if it improves the chances of staying cancer-free.
Description
This study is designed to see if curcumin, a natural supplement, can help prevent prostate cancer from returning in patients who have had surgery to remove their prostate. Participants will be randomly assigned to receive either curcumin or a placebo, and their health will be monitored to see if curcumin helps them stay cancer-free longer than those who do not take it.
Eligibility Criteria
Inclusion Criteria
- Have had surgery to remove the prostate due to prostate cancer.
- Cancer was confirmed to be in stages T1 to T3.
- No signs of cancer spreading to lymph nodes or other parts of the body.
- Considered low risk for cancer spreading based on medical guidelines.
- Have a Gleason score of 6 or 7 and a PSA level less than 20.
- Be in good general health with an ECOG status of 0 to 2.
- Have normal kidney, liver, and bone marrow function based on specific blood tests.
- Be between 30 and 80 years old at diagnosis, with a life expectancy of at least 3 years.
- May have small areas of cancer left at the edges of the removed tissue.
- No plans to receive additional hormone or radiation therapy.
- PSA level must be undetectable at the time of joining the study.
Exclusion Criteria
- More than 3 months have passed since surgery.
- Cancer was in stage T3b, T4, or had spread to lymph nodes.
- Visible cancer remains after surgery.
- Received hormone therapy before surgery.
- Have a history of gallbladder issues unless the gallbladder was removed.
- Received radiation therapy as the main treatment after surgery.
- Have a blood clotting test (INR) greater than 1.5.
- Liver enzymes (AST/ALT) are twice the normal limit or higher.
- Taking blood thinners, except for low-dose aspirin with close monitoring.
- Have a history of stomach or intestinal ulcers or untreated acid problems.
- Currently taking curcumin and unwilling to stop, or plan to take it during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UT Southwestern Medical Center | 75390 | Dallas | Texas |
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