Boswellia for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical University of South Carolina

Must not be taking: 5-lipoxygenase inhibitors, Anti-coagulants

Disqualifiers: Neoadjuvant therapy, Kidney disease, DVT, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Boswellia, a natural supplement, can cause changes in breast cancer tumors. It targets patients with breast cancer who are already scheduled for surgery. The trial suits women diagnosed with ductal carcinoma in situ or invasive breast cancer who are not receiving pre-surgery chemotherapy or hormone treatments. Participants will take Boswellia orally three times a day until the night before their surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that Boswellia is likely to be safe for humans?

Research has shown that Boswellia is usually well-tolerated. A past study found that Boswellia serrata, a type of Boswellia, was well-tolerated by breast cancer patients. Additionally, the Memorial Sloan Kettering Cancer Center states that Boswellia is generally safe to use. However, consulting with a healthcare provider is always wise. These findings suggest that Boswellia could be a safe choice for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often involve chemotherapy, radiation, and hormone therapies, Boswellia offers a unique approach. Boswellia is derived from a natural resin and is administered orally, which could mean fewer side effects compared to more aggressive treatments. Researchers are excited because Boswellia has anti-inflammatory properties and potential anti-cancer effects that might enhance recovery and reduce tumor growth with a different mechanism of action. This natural compound could complement existing treatments, providing a gentler option for patients while still targeting the cancer effectively.

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

Research suggests that Boswellia, a type of frankincense, may help treat breast cancer by slowing tumor growth. One study found that Boswellia serrata reduced the rate at which breast cancer cells multiply. Another study showed that Boswellia significantly decreased tumor growth compared to untreated groups. Additionally, some research indicates that Boswellia extracts might block certain pathways cancer cells use to spread. While more studies are needed, these early findings suggest that Boswellia could be a promising treatment for breast cancer. Participants in this trial will receive Boswellia at 800 mg by mouth three times a day, immediately after each meal, from the time surgical resection is scheduled until the night before surgical resection. ^{1 2 4 5 6}

Who Is on the Research Team?

Nancy Klauber-DeMore, MD, FACS

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10959833/

The anti-proliferative effects of a frankincense extract in ... Boswellia serrata inhibited breast cancer proliferation and was well-tolerated in a Phase Ia window of opportunity trial.

2. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2024/01/11/hollings-researchers-boswellia-frankincense-shows-anti-cancer-activity-in-small-trial

Hollings researchers find Boswellia, an extract of ... "We saw a statistically significant reduction in tumor proliferation compared to the non-treated group, so the implications are that Boswellia, ...

3. nature.com nature.com/articles/s41598-024-65170-6

Boswellia carterii n-hexane extract suppresses breast ... Boswellia carterii n-hexane extract suppresses breast cancer growth via induction of ferroptosis by downregulated GPX4 and upregulated ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1660-y

Boswellia frereana suppresses HGF-mediated breast cancer ... Our findings reveal that BFE was able to significantly suppress the influence of HGF in breast cancer cell motility and invasion in vitro.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3258268/

Boswellia sacra essential oil induces tumor cell-specific ... Our results demonstrate that Boswellia sacra essential oil suppresses Akt and ERK1/2 activation in human breast cancer cell lines except MDA-MB-231 cells.

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

Boswellia | Memorial Sloan Kettering Cancer ... Help reduce skin damage due to radiotherapy, in breast cancer patients. It's generally safe to use boswellia. However, talk with your healthcare ...