Quality of life measures in a phase I trial of noni

Abstract

8217 Background: Noni fruit extract, a popular dietary supplement used by cancer patients (pts) is derived from the traditional healing practices of Pacific Islanders and Asians. Its use is supported by preclinical evidence of anti-cancer activity and anecdotal evidence of helping patients feel and function better Methods: We conducted a phase I dose finding study with capsules containing 500mg ripe noni fruit extract in pts with advanced cancer. First dose level was 4 capsules (2 grams) daily, the highest recommended dosing of the commercial product. Subsequent dose levels were increased by 2 grams daily up to a maximum dose level of 10 grams (20 capsules) daily. A minimum of 5 pts at each dose level were observed for 28 days before new pts were entered at the next higher dose level. In addition to conventional toxicity and response measures, we measured quality of life and symptom status with QLQ C-30, Brief Fatigue Inventory (BFI), and CES-D, depression scale at baseline and every 4 weeks. Results: Pt. Characteristics: 29 pts were assessed for toxicity, quality of life/symptom status and pharmacokinetics. The distribution of performance status, extent of disease and prior treatment did not show any significant variation across the 5 dose levels. Toxicity: There were no adverse events (CTCAE criteria) attributable to noni. Quality of Life: Using a multilevel regression analysis of noni dose (2, 4, 6, 8, 10 grams) and week of study, there was a statistically significant [t(35)=-2.84, p=.006] decrease in pain interference with activities as measured by question 19 on the EORTC QLQ-C30 scale. Also, although not reaching statistical significance, consistent dose response effects were found for global health status (questions 29 & 30), physical functioning (questions 1–5) and fatigue (questions 10, 12, 18). There was no dose response relationship found for the BFI and CES-D measures. Tumor Response: No measured tumor regressions using RESIST criteria were noted. Conclusions: Quality of life measures may be useful for selecting dosing (maximum quality of life sustaining dose) for phase II efficacy trials of non toxic dietary supplements. No significant financial relationships to disclose.