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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03149081
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Boswellia Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A "Window Trial" on Boswellia, an Extract From Frankincense, for Breast Primary Tumors
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 frankinscense

Primary Outcome Measures :
  1. Change in tumor proliferation rate [ Time Frame: 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 Outcome Measures :
  1. Number of adverse events reported [ Time Frame: up to 84 days ]
    Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0

  2. Changes in tumors analyzed through immunohistochemistry [ Time Frame: up to 56 days ]
    Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03149081

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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alex Green    843-792-7573   
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Nancy Klauber-DeMore, MD, FACS Medical University of South Carolina
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Responsible Party: Medical University of South Carolina Identifier: NCT03149081    
Other Study ID Numbers: 102688
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases