A Simon's two-stage design trial evaluating the potential role of a kind of honey in preventing chemotherapy-hematopoietic toxicities.
Chemotherapy
Hematological adverse events
Neutropenia
Solid tumours
Supportive care
chemotherapy, (CT)
colony-stimulating factors, (CSFs)
febrile neutropenia, (FN)
tyrosine kinase inhibitors, (TKIs)
Journal
Journal of traditional and complementary medicine
ISSN: 2225-4110
Titre abrégé: J Tradit Complement Med
Pays: Netherlands
ID NLM: 101605474
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
29
01
2021
revised:
28
04
2021
accepted:
30
04
2021
entrez:
15
9
2021
pubmed:
16
9
2021
medline:
16
9
2021
Statut:
epublish
Résumé
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. 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. 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.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
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
METHODS
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
CONCLUSIONS
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.
Identifiants
pubmed: 34522641
doi: 10.1016/j.jtcme.2021.04.005
pii: S2225-4110(21)00054-7
pmc: PMC8427476
doi:
Types de publication
Journal Article
Langues
eng
Pagination
466-469Informations de copyright
© 2021 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC.
Déclaration de conflit d'intérêts
None.
Références
Control Clin Trials. 1989 Mar;10(1):1-10
pubmed: 2702835
Cancer. 2021 Jun 1;127(11):1827-1835
pubmed: 33524183
J Clin Oncol. 2005 Feb 20;23(6):1178-84
pubmed: 15718314
J Oncol Pract. 2015 Jan;11(1):47-54
pubmed: 25491042
Complement Ther Med. 2016 Apr;25:98-103
pubmed: 27062956
Complement Ther Med. 2020 Jun;51:102390
pubmed: 32507447
Molecules. 2019 Aug 21;24(17):
pubmed: 31438508
Clin Breast Cancer. 2018 Oct;18(5):380-386
pubmed: 29622384
Med Oncol. 2006;23(4):549-52
pubmed: 17303914
J Cancer Res Clin Oncol. 2021 Apr 17;:
pubmed: 33864520
J Clin Oncol. 2005 Nov 1;23(31):7974-84
pubmed: 16258098
J Clin Oncol. 2015 Oct 1;33(28):3199-212
pubmed: 26169616
J Natl Compr Canc Netw. 2009 Jan;7(1):99-108
pubmed: 19176210