The Anti-Proliferative Effects of a Frankincense Extract in a Window of Opportunity Phase Ia Clinical Trial for Patients with Breast Cancer

Abstract

BackgroundBoswellic acids, the active components of frankincense, have been shown to suppress tumor proliferation and apoptosis in vitro with a strong clinical trial safety pro le in patients with in ammatory diseases. We performed a Phase Ia window of opportunity trial of Boswellia serrata (B. serrata), the plant that produces frankincense, in patients with breast cancer to evaluate its biologic activity and safety. MethodsThis was a Phase Ia window of opportunity trial invasive breast cancer patients treated pre-operatively with B. Serrata (2400 mg/day PO) until the night before surgery. Para n-embedded sections from pretreatment diagnostic core biopsies were evaluated using a tunnel assay and immunohistochemistry staining with Ki-67 antibodies. A non-intervention control arm consisted of core and surgical tissue specimens from untreated patients was used to compare to patients treated with B. Serrata. The change in proliferation and apoptosis between diagnostic core specimens and specimens obtained at surgery was compared between the control and treatment groups using a two-tailed paired t-test. ResultsThere was an increase in percent change in proliferation from core biopsy to surgical excision in the control group (n = 18) of 54.6 ± 21.4%. In the B. serrata-treated group there was a reduction in proliferation between core biopsy and excision (n = 18) of 13.8 ± 11.7%. The difference between core and surgical specimens was statistically signi cant between the control and B. serrata-treated groups (p = 0.008). There was no difference in change in apoptosis. There were no serious adverse events related to the drug. ConclusionBoswellia serrata inhibited breast cancer proliferation in vivo in a clinically well-tolerated Phase Ia window of opportunity trial.