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

NCT ID: NCT03149081

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2024-04-29

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Boswellia

Intervention Type: DRUG

Boswellia is an extract from frankincense

Interventions

Boswellia

Boswellia is an extract from frankincense

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Klauber-DeMore, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

102688

Identifier Type: -

Identifier Source: org_study_id