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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Boswellia

• Registration Number: NCT03149081
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-08-31
• Status Verified: 2024-04
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boswellia	Boswellia	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.

Primary Outcome Measures

Name	Time	Method
Change in tumor proliferation rate	up to 56 days	Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia

Secondary Outcome Measures

Name	Time	Method
Number of adverse events reported	up to 84 days	Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0
Changes in tumors analyzed through immunohistochemistry	up to 56 days	Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States