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

NCT03149081 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 102688
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of adverse events reported

  up to 84 days

• Changes in tumors analyzed through immunohistochemistry

  up to 56 days

Study Arms (1)

Boswellia

EXPERIMENTAL

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

Interventions

Boswellia DRUG

Boswellia is an extract from frankincense

Boswellia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Frankincense

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Nancy Klauber-DeMore, MD, FACS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: August 31, 2017
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)