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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Boswellia

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Boswellia; Boswellia is an extract from frankincense

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Nancy Klauber-DeMore, MD, FACS, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): April 29, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 102688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No