题名

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

DOI

10.1016/j.jtcme.2021.04.005

作者

Andrea Pietro Sponghini；David Rondonotti；Francesca Platini；Tiziana Cena；Daniela Ferrante；Florian Stratica；Alice Gatti；Corrado Magnani；Alessandra Gennari

关键词

Chemotherapy ； Solid tumours ； Hematological adverse events ； Neutropenia ； Supportive care

期刊名称

Journal of Traditional and Complementary Medicine

卷期/出版年月

11卷5期（2021 / 09 / 01）

页次

466 - 469

内容语文

英文
中文摘要

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.
主题分类 醫藥衛生 > 中醫藥學
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