Clinical trial NCT03149081: A "Window Trial" on Boswellia for Breast Cancer Primary Tumors
Official title: A "Window Trial" on Boswellia, an Extract From Frankincense, for Breast Primary Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in tumor proliferation rate
timeFrame: up to 56 days
Secondary outcomes:
measure: Number of adverse events reported
timeFrame: up to 84 days
measure: Changes in tumors analyzed through immunohistochemistry
timeFrame: up to 56 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Nancy Klauber-DeMore, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: