{"title":"The safety and tolerability of Annona muricata leaf product in people living with cancer: Study protocol","authors":"","doi":"10.1016/j.aimed.2024.06.004","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>The objective of this study was to design a clinical study protocol to investigate the safety and tolerability of <em>Annona muricata</em>, in people living with advanced malignancy. Anecdotal clinical evidence suggests this herb has potential anti-cancer activity. There are numerous pre-clinical studies detailing <em>Annona muricata’</em>s main bioactive constituents. To date, clinical studies evaluating the efficacy, safety and tolerability are limited.</p></div><div><h3>Design</h3><p>This phase 1 open label study will involve people living with stage III and IV cancers of any type, who are not undergoing chemotherapeutic treatment.</p></div><div><h3>Methods</h3><p>The primary outcome is safety and tolerability of an <em>Annona muricata</em> leaf product as measured by participants’ self-reporting of adverse effects experienced and the proportion of participants completing the study. Secondary outcomes include biomarkers of inflammation and immune function, disease status and self-reported quality of life scores. Participants (n = 24) will be allocated to one of two groups for 12 weeks. Participants will commence at different timepoints and be assigned to either 530 mg or 1060 mg of <em>Annona muricata</em> daily<em>.</em> The study has been approved by the Human Research Ethics Committee Bellberry and will be reported in compliance with the SPIRIT statement. This study has been registered with the Australian New Zealand Clinical Trials Register.</p></div><div><h3>Results and conclusions</h3><p>The results of this study will provide safety and tolerability data for clinicians involved in the care of people living with cancer who choose to use <em>Annona muricata</em> products as an integrative approach to their healthcare. The results of this study will inform further research about the potential role of <em>Annona muricata</em> in cancer.</p></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2212958824000624/pdfft?md5=587064c0ab6609e83f2cec5f81581411&pid=1-s2.0-S2212958824000624-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958824000624","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives
The objective of this study was to design a clinical study protocol to investigate the safety and tolerability of Annona muricata, in people living with advanced malignancy. Anecdotal clinical evidence suggests this herb has potential anti-cancer activity. There are numerous pre-clinical studies detailing Annona muricata’s main bioactive constituents. To date, clinical studies evaluating the efficacy, safety and tolerability are limited.
Design
This phase 1 open label study will involve people living with stage III and IV cancers of any type, who are not undergoing chemotherapeutic treatment.
Methods
The primary outcome is safety and tolerability of an Annona muricata leaf product as measured by participants’ self-reporting of adverse effects experienced and the proportion of participants completing the study. Secondary outcomes include biomarkers of inflammation and immune function, disease status and self-reported quality of life scores. Participants (n = 24) will be allocated to one of two groups for 12 weeks. Participants will commence at different timepoints and be assigned to either 530 mg or 1060 mg of Annona muricata daily. The study has been approved by the Human Research Ethics Committee Bellberry and will be reported in compliance with the SPIRIT statement. This study has been registered with the Australian New Zealand Clinical Trials Register.
Results and conclusions
The results of this study will provide safety and tolerability data for clinicians involved in the care of people living with cancer who choose to use Annona muricata products as an integrative approach to their healthcare. The results of this study will inform further research about the potential role of Annona muricata in cancer.
期刊介绍：
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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