Curcumin for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

Must not be taking: Anticoagulants, Platelet inhibitors, others

Disqualifiers: Neoadjuvant therapy, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 56 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether curcumin, a natural compound in turmeric, can alter breast cancer tumors. Participants will take curcumin orally twice a day before their scheduled surgery. The trial seeks women with breast cancer tumors at least 1 cm in size, who are not currently receiving certain cancer treatments and have no major liver or kidney issues. This study could clarify curcumin's effects on breast cancer, potentially leading to new treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore curcumin's potential benefits.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they are anti-coagulants, platelet inhibitors, or drugs metabolized by specific enzymes (CYP3A4, CYP1A2, CYP2A6) or interact with P-glycoprotein. The trial does not specify a washout period, but you should discuss your current medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that curcumin is generally safe for use. Studies have found it to be well-tolerated without causing major side effects. In individuals with advanced breast cancer, curcumin has been used safely, even alongside other cancer treatments. Although this trial is just beginning, earlier studies suggest that curcumin is unlikely to cause harm and may be a safe choice for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Curcumin is unique because it is derived from turmeric, a natural spice, and offers a novel approach to treating breast cancer. Unlike standard treatments like chemotherapy and hormone therapy, which can have significant side effects, curcumin is known for its anti-inflammatory and antioxidant properties and may have fewer adverse effects. Researchers are excited about curcumin because it targets cancer cells by potentially interfering with their growth and survival mechanisms, providing a complementary option to existing therapies.

What evidence suggests that curcumin might be an effective treatment for breast cancer?

Research has shown that curcumin, a substance in turmeric, might help treat breast cancer. Studies have found that it can slow the growth and spread of cancer cells by making it harder for them to multiply and move. Curcumin has proven effective in various types of breast cancer, including estrogen receptor-positive (ER+) and triple-negative breast cancer (TNBC). Early results suggest that curcumin could be a promising addition to cancer treatment plans. In this trial, participants will take 500mg of curcumin by mouth twice a day, immediately after each meal, from the time surgical resection is scheduled until the night before the procedure. ^{1 2 5 6 7}

Who Is on the Research Team?

Nancy DeMore, MD, FACS

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I am currently receiving chemotherapy or hormone therapy before surgery.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive curcumin at 500mg by mouth twice a day from the time surgical resection is scheduled until the night before surgical resection

Up to 56 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin

Trial Overview 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.

How Is the Trial Designed?

Group I: Curcumin Experimental Treatment 1 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.

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3706856/

The Effect of Curcumin on Breast Cancer Cells - PMC It has been found that curcumin inhibits the migratory activity of breast cancer cells, proliferative rate, adhesion, and invasion through down-regulating the ...

2. cancer.gov cancer.gov/about-cancer/treatment/cam/hp/curcumin-pdq

Curcumin and Cancer (PDQ®) - NCI Data from early-phase trials of the safety and effectiveness of curcumin-containing products in cancer treatment are at most from pilot trials ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2472630322014431

Curcumin in Treating Breast Cancer: A Review Curcumin, an active derivative from turmeric, has been reported to have anticancer and chemoprevention effects on breast cancer.

4. mdpi.com mdpi.com/1422-0067/25/21/11492

Curcumin Administration Routes in Breast Cancer Treatment In the context of breast cancer, curcumin has been shown to be effective in ER+ and TNBC [19]. In vitro, curcumin reduces proliferation, induces ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hsr2.70052

Curcumin's effect in advanced and metastatic breast ... A large number of studies have explored the benefits of curcumin and its antineoplastic effects, making it a good candidate for cancer treatment ...

6. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/turmeric

Turmeric Furthermore, curcumin may serve as a useful adjunct to cancer treatments: When combined with docetaxel and gemcitabine, it was found to be safe ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0944711320300507

Efficacy and safety of curcumin in combination with ... The preclinical data in breast cancer models have shown additive/synergistic effects by adding curcumin to paclitaxel (Ganta and Amiji, 2009; ...