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

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Boswellia

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boswellia

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of adverse events reported

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

Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors.

Full Information

NCT ID

NCT03149081

First Posted

May 4, 2017

Last Updated

September 22, 2023

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT03149081

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 31, 2017 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Boswellia

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Boswellia

Intervention Description

Boswellia is an extract from frankincense

Primary Outcome Measure Information:

Title

Change in tumor proliferation rate

Description

Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia

Time Frame

up to 56 days

Secondary Outcome Measure Information:

Title

Number of adverse events reported

Description

Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0

Time Frame

up to 84 days

Title

Changes in tumors analyzed through immunohistochemistry

Description

Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors.

Time Frame

up to 56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Klauber-DeMore, MD, FACS

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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