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Polyphenol
Curcumin for Breast Cancer
Phase 1
Waitlist Available
Led By Nancy DeMore, MD, FACS
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 6 sections of unstained slides should be obtained. If sufficient slides or tissue is unavailable, the patient will be excluded from the trial
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 days
Awards & highlights
Study Summary
This trial will study whether taking curcumin orally will have any effect on primary breast cancer tumors in patients.
Who is the study for?
This trial is for adults with invasive breast cancer (stages I-III) who can consent to the study, have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, and have adequate organ function. They must be scheduled for surgery within 5-56 days from starting the trial and agree to use approved birth control if of childbearing potential.Check my eligibility
What is being tested?
The study tests whether taking curcumin orally causes changes in primary breast cancer tumors before surgery. Participants will receive curcumin supplements and researchers will observe any biological effects on their tumor tissue.See study design
What are the potential side effects?
Curcumin may cause digestive issues like stomach ulcers or hyperacidity, gallstones, or interact with certain medications affecting liver enzymes and drug transport proteins. It's not suitable for those with bile duct obstruction, kidney stones risk, severe kidney/liver disease, or those on blood thinners.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide at least 6 unstained slides for testing.
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I am fully active or can carry out light work.
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My breast cancer is confirmed and the tumor is at least 1 cm big.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 84 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 84 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in tumor proliferation rate
Secondary outcome measures
Number of adverse events reported
Trial Design
1Treatment groups
Experimental Treatment
Group I: CurcuminExperimental Treatment1 Intervention
Curcumin will be given at 500mg by mouth twice a day, immediately after each meal. Curcumin will be given from the time surgical resection is scheduled until the night before surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
2017
Completed Phase 4
~1050
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,368 Total Patients Enrolled
10 Trials studying Breast Cancer
627 Patients Enrolled for Breast Cancer
Nancy DeMore, MD, FACSPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving chemotherapy or hormone therapy before surgery.My blood and organs are functioning well.I understand the risks and benefits of the study and can give my consent.I can provide at least 6 unstained slides for testing.I am not taking any medications listed under the MSKCC's herb-drug interactions section.I have issues like bile duct obstruction, gallstones, kidney stones, stomach ulcers, or acid reflux.I have severe kidney disease or moderate liver problems.I am using an approved method of birth control or practicing abstinence.I am currently taking blood thinners or medication to prevent blood clots.I am fully active or can carry out light work.My surgery at MUSC is scheduled between 5 and 56 days from now.I can follow the study's requirements and attend all follow-ups.My breast cancer is confirmed and the tumor is at least 1 cm big.I am taking medication that affects my liver enzymes.I am 18 years old or older.I am taking medication that interacts with P-gp.I am a woman who can have children and agree to use birth control and test negative for pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Curcumin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can prolonged use of Curcumin lead to adverse health effects?
"As Curcumin is currently in the first phase of clinical trials, there exists minimal data that can be used to evaluate its safety and efficacy; thus, it was assigned a score of 1."
Answered by AI
How many participants are enrolled in this research endeavor?
"This research is not currently open for recruitment. The trial was initially announced on January 29th 2020, and the listing has been refreshed as recently as August 9th 2022. However, if you are looking to join a similar study there are 2,600 trials actively enrolling patients dealing with breast cancer and 17 clinical studies related to Curcumin that can accept volunteers."
Answered by AI
Are researchers currently seeking participants for this research endeavor?
"This trial is no longer enrolling new participants; the initial posting was on January 29th 2020 and it was last updated on August 9th 2022. For those seeking alternative studies, 2600 medical trials are actively recruiting patients with breast cancer while 17 clinical studies require volunteers to assess Curcumin's efficacy."
Answered by AI
Has the therapeutic potential of Curcumin been evaluated previously?
"At present, 17 clinical trials are underway examining the efficacy of Curcumin. Three of these studies have advanced to Phase 3 while 21 medical sites across the United States are running trials with this medication. Major centres include Farmington Hills, Michigan."
Answered by AI
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