Clinical trial · Interventional
A "Window Trial" on Boswellia for Breast Cancer Primary Tumors
A "Window Trial" on Boswellia, an Extract From Frankincense, for Breast Primary Tumors
NCT03149081CI-TRIAL-00076579completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Boswellia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Boswellia
- 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.
- interventionNames
- Drug: Boswellia
Primary outcomes (1)
- measure
- Change in tumor proliferation rate
- timeFrame
- up to 56 days
- description
- Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia
Secondary outcomes (2)
- measure
- Number of adverse events reported
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.