A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities.
| Title: | 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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| Authors: | Sponghini AP; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy.; Rondonotti D; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy.; Platini F; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy.; Cena T; Department of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.; Ferrante D; Department of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.; Stratica F; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy.; Gatti A; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy.; Magnani C; Department of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.; Gennari A; Division of Oncology, University Hospital 'Maggiore Della Carità', 28100, Novara, Italy. |
| Source: | Journal of traditional and complementary medicine [J Tradit Complement Med] 2021 May 05; Vol. 11 (5), pp. 466-469. Date of Electronic Publication: 2021 May 05 (Print Publication: 2021). |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Elsevier B.V. on behalf of the Center for Food and Biomolecules, National Taiwan University Country of Publication: Netherlands NLM ID: 101605474 Publication Model: eCollection Cited Medium: Print ISSN: 2225-4110 (Print) Linking ISSN: 22254110 NLM ISO Abbreviation: J Tradit Complement Med Subsets: PubMed not MEDLINE |
| Imprint Name(s): | Publication: Amsterdam : Elsevier B.V. on behalf of the Center for Food and Biomolecules, National Taiwan University; Original Publication: Philadelphia, PA : [Taipei] : Wolters Kluwer Health, Medknow ; Committee on Chinese Medicine and Pharmacy |
| Abstract: | 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.; (© 2021 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC.) |
| Competing Interests: | None. |
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| Contributed Indexing: | Keywords: Chemotherapy; Hematological adverse events; Neutropenia; Solid tumours; Supportive care; chemotherapy, (CT); colony-stimulating factors, (CSFs); febrile neutropenia, (FN); tyrosine kinase inhibitors, (TKIs) |
| Entry Date(s): | Date Created: 20210915 Latest Revision: 20220426 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8427476 |
| DOI: | 10.1016/j.jtcme.2021.04.005 |
| PMID: | 34522641 |
| Database: | MEDLINE |
Journal Article