The effect of an Annona muricata leaf extract on nutritional status and cytotoxicity in colorectal cancer: a randomized controlled trial.

BACKGROUND AND OBJECTIVES Annona muricata leaf infusion has traditionally been consumed to maintain health, but is now considered for use in treating cancer patients. The objective of this study was to elucidate the effects of A. muricata leaf extract in humans and human cell lines. METHODS AND STUDY DESIGN Thirty outpatients with colorectal cancer who had undergone primary tumor resection were enrolled in a randomized double-blind placebo- controlled pre-post-trial. They were divided into two groups: those who ingested A. muricata leaf extract (n=14) and those who ingested a placebo (n=14) daily for 8 weeks. Twenty-eight subjects completed the trial; they were equally distributed between the two groups. Serum from patients of both groups was compared for cytotoxicity against colorectal cancer cell lines. The nutritional status of patients was monitored throughout the study. RESULTS Ex vivo and clinical studies showed higher cytotoxicity in the supplemented group compared with the placebo group. Further research is required to investigate the long-term effect of A.muricata leaf extract, particularly on parameters directly related to cytotoxic activity toward colorectal cancer cells and nutrition status.