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 530mg or 1060mg 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.