The anti-proliferative effects of a frankincense extract in a window of opportunity phase ia clinical trial for patients with breast cancer.

PURPOSE: Boswellic acids, active components of frankincense, suppress tumor proliferation in vitro with a strong clinical trial safety profile in patients with inflammatory diseases. We performed a Phase Ia window of opportunity trial of Boswellia serrata (B. serrata) in patients with breast cancer to evaluate its biologic activity and safety. METHODS: Patients with invasive breast cancer were treated pre-operatively with B. Serrata (2400 mg/day PO) until the night before surgery for a median of 11 days (SD 6 days; range: 5-23 days). Paraffin-embedded sections from pretreatment diagnostic core biopsies and post-treatment surgical excisions were evaluated using a tunnel assay and immunohistochemistry staining with Ki-67 antibodies. A non-intervention retrospective control arm consisting of core and surgical tissue specimens from untreated patients was used to compare patients treated with B. Serrata. The change in proliferation and apoptosis between diagnostic core specimens and surgical specimens was compared between the control and treatment groups using a two-tailed paired t-test. RESULTS: Twenty-two patients were enrolled, of which 20 received treatment, and 18 had sufficient tissue for IHC. There 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%. This difference was statistically significant 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. CONCLUSION: Boswellia serrata inhibited breast cancer proliferation and was well-tolerated in a Phase Ia window of opportunity trial.

Music Therapy in Dialysis Access Procedures With Moderate Sedation.

BACKGROUND: The aim was to evaluate the effects of music on patients' anxiety and satisfaction after undergoing dialysis access procedures under moderate sedation. METHODS: Patients (n = 30) undergoing moderate sedation for dialysis access procedures were evaluated at a single institution. Each patient filled out a survey preoperatively and postoperatively using the short form State-Trait Anxiety Inventory (STAI-6). Patient-selected music was provided by using a MP3 player with noise canceling headphones. RESULTS: Postoperatively, 77% of patients perceived music intervention as very or extremely helpful in decreasing anxiety during the procedure. Further, 93% of patients were somewhat or very satisfied with their procedure. The average pain rating was 3.1 on a scale of 0-10, in which 70% of patients had no to mild pain and 30% of patients rated moderate to severe pain. In comparison to prior procedures without music, 63% of patients rated better experience with the music intervention, 37% rated a similar experience, and 3.7% rated having a worse experience. Approximately, 93% of patients were willing to repeat procedure with music and would recommend it to other patients. Preoperative anxiety average score was 35.6 ± 13 and was reduced postoperatively to 28.9 ± 12.9 (P = .006). Preoperatively, 23% of patients rated high anxiety and postoperatively only 6.7% of patients rated high anxiety (P = .016). CONCLUSION: Music is an easy, feasible, inexpensive intervention that may reduce patients' anxiety and improve satisfaction during moderate sedation procedures and in the postoperative period.