The safety and tolerability of Annona muricata leaf product in people living with cancer: study protocol

Abstract Background: Annona muricata , also known as graviola, soursop and guanabana is a herbal product used by people living with cancer. 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. This study aims to investigate the safety and tolerability of Annona muricata leaf in people living with advanced malignancy. Methods: This open label pilot study will involve people living with stage III and IV cancers of any type, who are not undergoing chemotherapeutic treatment. The primary outcome is safety and tolerability of an Annona muricata leaf product in this population assessed 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 (2022-04-420) and will be conducted in compliance with the SPIRIT statement. Discussion: 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. Trial registration: This study has been registered with the Australian New Zealand Clinical Trials Register (ACTRN 12622001288718)