A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities
| العنوان: | A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities |
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| المؤلفون: | Daniela Ferrante, David Rondonotti, Andrea Pietro Sponghini, Florian Stratica, Francesca Platini, Corrado Magnani, Alessandra Gennari, Alice Gatti, Tiziana Cena |
| المصدر: | Journal of Traditional and Complementary Medicine |
| بيانات النشر: | Elsevier BV, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Neutropenia, Short Communication, medicine.medical_treatment, 0211 other engineering and technologies, Phases of clinical research, 02 engineering and technology, 01 natural sciences, colony-stimulating factors, (CSFs), Hematological adverse events, Internal medicine, febrile neutropenia, (FN), 021105 building & construction, Clinical endpoint, Chemotherapy, Medicine, Adverse effect, Solid tumours, business.industry, chemotherapy, (CT), medicine.disease, 0104 chemical sciences, Discontinuation, Clinical trial, 010404 medicinal & biomolecular chemistry, Complementary and alternative medicine, Tolerability, tyrosine kinase inhibitors, (TKIs), business, Supportive care |
| الوصف: | 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. Graphical abstract Image 1 |
| تدمد: | 2225-4110 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3fd50660baad84bd21836be88ac1fb26 https://doi.org/10.1016/j.jtcme.2021.04.005 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3fd50660baad84bd21836be88ac1fb26 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 22254110 |
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