A "Window Trial" on Boswellia for Breast Cancer Primary Tumors

Breast Cancer Clinical Trial

Official title:

A "Window Trial" on Boswellia, an Extract From Frankincense, for Breast Primary Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149081
• Other study ID #: 102688
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2017
• Est. completion date: April 29, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.

Description:

To determine whether oral administration of Boswellia serrata causes biological changes related to angiogenesis (CD31), apoptosis (DNA fragmentation), and cell proliferation (Ki67) in primary tumors of breast cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) = 1.0 cm on mammogram, ultrasound, MRI, or physical exam

• 18 years of age or older

• Subject must understand risks and benefits of the protocol and be able to give informed consent

• Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result before and throughout the study

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate hematologic and end organ function

• Ability and capacity to comply with the study and follow-up procedure

• Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1.

• 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.

Exclusion Criteria:

• Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy

• Subjects with end-stage kidney disease and/or grade II liver dysfunction

• Subject has active or history of deep vein thrombosis (DVT)

• Subject has a history of coagulopathies or hematological disorders

• Subjects who are pregnant or are lactating.

• Subjects already taking drugs known to be 5-lipoxygenase inhibitors (Refer to section 5)

• Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-Glycoprotein (P-Gp) (Refer to section 5.)

• Subjects taking anti-coagulants or platelet inhibitors (Refer to section 5)

• Subjects with bowel obstruction

• Subjects undergoing emergency surgery.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Boswellia
Boswellia is an extract from frankincense

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tumor proliferation rate	Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia	up to 56 days
Secondary	Number of adverse events reported	Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0	up to 84 days
Secondary	Changes in tumors analyzed through immunohistochemistry	Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors.	up to 56 days