What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, hormone therapy, and radiation therapy, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections. Hormone therapy may lead to hot flashes, mood swings, and an increased risk of blood clots. Radiation therapy can result in skin irritation, fatigue, and localized pain. Treatments with anti-inflammatory and antioxidant properties, like curcumin, are being studied for their potential to mitigate some of these side effects, but their efficacy and safety profiles are still under investigation.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of targeted therapies, hormone therapies, and chemotherapies. Targeted therapies such as trastuzumab (Herceptin) and pertuzumab (Perjeta) are used for HER2-positive breast cancer. Hormone therapies like tamoxifen and aromatase inhibitors (e.g., letrozole, anastrozole) are used for hormone receptor-positive breast cancer. Chemotherapies such as doxorubicin and paclitaxel are also commonly used. While curcumin is being studied for its anti-inflammatory and antioxidant properties, these characteristics are not the primary focus of current FDA-approved breast cancer treatments.

What other types of research exist?

Promising alternatives to curcumin for breast cancer patients include green tea polyphenols, which have shown potential in inhibiting cancer cell growth and enhancing survival in various cancers. Additionally, aspirin and other NSAIDs have been studied for their anti-inflammatory properties and potential to reduce cancer mortality. Vitamin D supplementation has also been associated with improved survival outcomes in cancer patients. These alternatives should be discussed with a healthcare provider to determine their suitability and integration into a comprehensive treatment plan.

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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

Must not have

Subjects taking any of the medications listed under Other Herb-Drug interactions according to the Memorial Sloan Kettering Cancer Center in section 5

Subjects with bile duct obstruction, gallstones, predisposition to kidney stones, or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 84 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if taking curcumin, a substance found in turmeric, by mouth can cause changes in breast cancer cells. It focuses on patients with primary breast tumors. The researchers want to see if curcumin can help kill these cancer cells and stop them from growing. Curcumin, the active component of turmeric, has been extensively studied for its anticancer properties, including inhibiting tumor growth and inducing cancer cell death.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications listed under the MSKCC's herb-drug interactions section.

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I have issues like bile duct obstruction, gallstones, kidney stones, stomach ulcers, or acid reflux.

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I have severe kidney disease or moderate liver problems.

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I am currently taking blood thinners or medication to prevent blood clots.

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I am taking medication that interacts with P-gp.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in tumor proliferation rate

Secondary study objectives

Number of adverse events reported

Side effects data

From 2023 Phase 4 trial • 58 Patients • NCT04205929

Migraine headache

Stomach cramps

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Curcumin Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1070

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery and radiation aim to remove or destroy cancer cells locally. Chemotherapy uses drugs to kill rapidly dividing cells throughout the body. Hormone therapy blocks hormones like estrogen that can promote cancer growth, while targeted therapy focuses on specific molecules involved in cancer cell growth and survival. Curcumin, with its anti-inflammatory and antioxidant properties, is being studied for its potential to cause biological changes in primary breast tumors. These properties may help reduce inflammation and oxidative stress, which are known to contribute to cancer progression, making curcumin a promising complementary treatment option.