Evidence map›Paper›PMID 34522641›Full record

ArticleJournal of traditional and complementary medicine2021

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

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

Open access · diamondAbstract read
In one paragraph

Article in Journal of traditional and complementary medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Chemical Composition and the Anticancer, Antimicrobial, and Antioxidant Properties ofEvidence-based complementary and alternative medicine : eCAM · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Andrea Pietro SponghiniDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
David RondonottiDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Francesca PlatiniDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Tiziana CenaDepartment of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.
Daniela FerranteDepartment of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.
Florian StraticaDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Alice GattiDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Corrado MagnaniDepartment of Translational Medicine, Unit of Medical Statistics, University of Eastern Piedmont and Cancer Epidemiology, CPO Piemonte, Novara, Italy.
Alessandra GennariDivision of Oncology, University Hospital "Maggiore Della Carità", 28100, Novara, Italy.
Università degli Studi del Piemonte Orientale “Amedeo Avogadro” · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimHematopoietic 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

conclusionFrom 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.

Indexed as

Chemotherapychemotherapy, (CT)colony-stimulating factors, (CSFs)febrile neutropenia, (FN)Hematological adverse eventsNeutropeniaSolid tumoursSupportive caretyrosine kinase inhibitors, (TKIs)

Identifiers

PMID34522641
PMCPMC8427476
OpenAlexW3159041545

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.