{"title":"癌症患者服用鼠尾草叶产品的安全性和耐受性：研究方案","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. 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引用次数: 0
摘要
研究目的：本研究旨在设计一项临床研究方案，以调查晚期恶性肿瘤患者对鼠李子（Annona muricata）的安全性和耐受性。临床轶事证据表明，这种草药具有潜在的抗癌活性。许多临床前研究详细介绍了鼠李子的主要生物活性成分。方法主要研究结果是鼠李子叶产品的安全性和耐受性，通过参与者对不良反应的自我报告和完成研究的参与者比例来衡量。次要结果包括炎症和免疫功能的生物标志物、疾病状况和自我报告的生活质量评分。参与者（n = 24）将被分配到两组中的一组，为期 12 周。参与者将从不同的时间点开始，每天服用530毫克或1060毫克鼠尾草。该研究已获得贝尔贝里人类研究伦理委员会（Human Research Ethics Committee Bellberry）的批准，并将按照SPIRIT声明进行报告。本研究已在澳大利亚-新西兰临床试验注册机构注册。结果与结论本研究的结果将为临床医生提供安全性和耐受性数据，以帮助选择使用鼠李子茴香产品作为综合保健方法的癌症患者。这项研究的结果将为进一步研究鼠李子对癌症的潜在作用提供信息。
The safety and tolerability of Annona muricata leaf product in people living with cancer: Study protocol
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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