Boswellia for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 8 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if taking Boswellia serrata by mouth can change certain biological processes in breast cancer tumors. It focuses on whether the supplement can stop new blood vessels from forming, make cancer cells die, or slow down their growth. The goal is to find out if Boswellia could be a helpful treatment for breast cancer patients. Boswellia serrata has long been used in traditional medicine for its anti-inflammatory properties and has shown potential in preclinical studies for its anti-cancer effects.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically those that are 5-lipoxygenase inhibitors, interact with OATP1B3, MRP2, or P-Glycoprotein, or are anti-coagulants or platelet inhibitors.

Is Boswellia safe for use in humans?

Boswellia, also known as frankincense, has been used in traditional medicine and is generally considered safe with mild side effects. However, some studies have shown that in higher doses, it may cause liver toxicity, so it's important to use it under medical supervision. ^{1 2 3 4 5}

How does the treatment Boswellia differ from other breast cancer treatments?

Boswellia, a natural plant product, is unique in its potential anti-inflammatory and anti-cancer properties, which may offer a complementary approach to traditional breast cancer treatments like surgery, chemotherapy, and radiotherapy. Unlike conventional treatments, Boswellia might help reduce inflammation, which is linked to cancer progression, and could be used alongside standard therapies to enhance their effectiveness. ^{6 7 8 9 10}

Research Team

Nancy Klauber-DeMore, MD, FACS

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults with breast cancer who are scheduled for surgery, can follow study procedures, and have a tumor at least 1.0 cm large. They must be in good health otherwise, not on certain drugs that affect body transport proteins or blood clotting, and not pregnant or breastfeeding.

Inclusion Criteria

I can provide at least 6 unstained slides for testing.

I understand the risks and benefits of the study and can give my consent.

I agree to use birth control and will provide negative pregnancy tests before and during the study.

Exclusion Criteria

Subjects who are pregnant or are lactating.

I am currently taking medication that inhibits 5-lipoxygenase.

I am not taking medication that affects certain drug transporters.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Boswellia at 800mg by mouth three times a day from the time surgical resection is scheduled until the night before surgical resection

up to 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 12 weeks

Treatment Details

Interventions

• Boswellia

Trial Overview The trial is testing the effects of Boswellia taken orally on biological changes in primary breast cancer tumors before surgery to remove them.

Participant Groups

Group I: Boswellia Experimental Treatment 1 Intervention

Boswellia will be given at 800mg by mouth three times a day, immediately after each meal. Boswellia will be given from the time surgical resection is scheduled until the night before surgical resection.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-tumor and anti-carcinogenic activities of triterpenoid, beta-boswellic acid. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Anti-inflammatory and anti-cancer activities of frankincense: Targets, treatments and toxicities. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Boswellia serrata in mouse models of chemically induced colitis. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

Boswellia serrata resin extract alleviates azoxymethane (AOM)/dextran sodium sulfate (DSS)-induced colon tumorigenesis. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Methanolic extract of Boswellia serrata exhibits anti-cancer activities by targeting microsomal prostaglandin E synthase-1 in human colon cancer cells. [2018]

6. Greece pubmed.ncbi.nlm.nih.gov

Ruanjian Sanjie decoction exhibits antitumor activity by inducing cell apoptosis in breast cancer. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Medicinal Herbs Used in Traditional Management of Breast Cancer: Mechanisms of Action. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Natural Products for the Prevention, Treatment and Progression of Breast Cancer. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of Cimicifuga racemosa (L.) Nutt on sexual function in women receiving tamoxifen for breast cancer. [2023]