A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities.

BACKGROUND AND AIM: Hematopoietic toxicities are a serious consequence of myelosuppressive CT that may result in dose reductions, delays or even discontinuation of CT, which, in turn, may compromise patient outcomes. Concerns about tolerability and costs of CSFs are still ongoing, therefore the potential use of supportive therapeutics agents are still of interest. EXPERIMENTAL PROCEDURE: We performed a monocentric, phase II study using Simon's two-stage design. The primary endpoint was the evaluation of the potential clinical benefit of a special kind of honey (Life-Mel Honey) administered prophylactically to reduce the incidence of hematopoietic toxicities following chemotherapy. We have enrolled patients undergoing adjuvant or first-line chemotherapy. RESULTS AND CONCLUSION: From November 2013 to May 2014 (First stage) and from November 2014 to April 2016 (Second stage), 39 patients were enrolled at our Institution. The majority of patients was male (24/39, 61.5%), medium age was 60.4 years (range 34-77 years). The median follow up was 74.5 days (SD +/- 28.5). Overall, the majority of patients could underwent their chemoterapy with a regular schedule (25/39, 64.1%), while 9/39 patients (23.1%) need to delay chemotherapy due to hematological adverse events of various grade. Ten/39 patients (25.6%) had a grade 1 neutrophils count decreased, 56.4% a grade 1 platelets count decrease and 64.1% a grade 1 hemoglobin decrease. Therefore, Life-Mel Honey showed an interesting profile to reduce hematological toxicities. The proportion of responses is sufficiently high to recommend this honey to go to a next step in the clinical trial phase.

The Impact of a New "Inverted Arch" Prosthetic Annuloplasty Ring on the Mitral Valve's 3-D Motion: An Experimental Ex-Vivo Study.

This experimental study aimed to evaluate the ex-vivo three-dimensional (3-D) motion of the Inverted Arch Ring (IAR), an innovative new design concept for a flexible incomplete annuloplasty prosthesis with an incorporated stabilizing rigid arch that can be used in correcting mitral valve regurgitation. Twenty explanted porcine hearts were placed in a circulation simulation system. Ultrasonometry transducers implanted in the mitral annulus were used to measure the 3-D valvular motion during a simulated cardiac cycle. Annular distance measurements were recorded and compared in each heart before and after the implantation of the IAR prosthesis at pressures corresponding to mid-systole and mid-diastole. Distances measured in mid-systole and mid-diastole demonstrated no significant differences in annular motion or in valve areas either prior to or after IAR implantation. Therefore, the results of this study confirm the minimal effects exerted by the IAR prosthesis on the mitral valve's 3-D motion during a simulated cardiac cycle.