Breast Cancer
Conditions
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.
Interventions
DRUGBoswellia
Boswellia is an extract from frankincense
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed