QUALITY OF LIFE RESEARCH Official Journal of the International Society for Quality of Life Research 14(9):P-70/1342, 2005
Abstract presented at 12th Annual Conference of the International Society for Quality of Life Research (ISOQOL) Quality of Life (QOL) Assessment in a Phase I Trial of Noni
Issell, B.F., Gotay, C.C., Pagano, I. Cancer Research Center of Hawaii, University of Hawaii, Honolulu, HI

The objective of this study was to identify the maximally tolerated dose (MTD) of noni. Noni fruit extract is a popular dietary supplement that is widely used as a complementary and alternative medicine (CAM) by cancer patients. Twenty-nine patients were assessed. The distribution of performance status, extent of disease and prior treatment did not vary across dose levels. A multilevel regression analysis of noni dose (2, 4, 6, 8, 10 g) and week of study showed a statistically significant [t(35) = 2.84, P = 0.006] decrease in pain interference with activities as measured by question 19 on the EORTC QLQ-C30 scale. Also, consistent marginally significant dose–response effects were found for global health status, physical functioning and fatigue. No effects were found on the BFI and CES-D. No adverse toxic events attributable to noni and no measured tumor regressions were seen. Conclusion: QOL measures may be useful for selecting dosing for subsequent phase II/III efficacy trials, particularly for CAM agents that are commonly used but of unproven value.