Phase I Study of Noni in Cancer Patients

Trial Information

Phase I Study of Noni in Cancer Patients

This Phase I study of noni in cancer patients represents a first step in the systematic
study of Complementary and Alternative Medicine (CAM) practices that draw on Asian and
Pacific Island cultural traditions of healing to control cancer and its related symptoms.
Noni, extracted from Morinda citifolia or the Indian mulberry plant, is included in the
traditional pharmacopoeias of Native Hawaiians, other Pacific Islanders and Asian
populations, and has been used to treat various diseases for hundreds of years. It is now
commonly taken by cancer patients based on purported usefulness in the disease although
there is little scientific evidence to either support or refute these claims. A large
marketing enterprise and at least eleven different suppliers supports the food supplement's
popularity. The broad long range objectives which this study will initiate are to define the
usefulness of noni extracts for cancer patients. The hypothesis to be tested is that noni at
a specified dosing provides cancer patients with a sufficient benefit to toxicity profile to
be useful as a therapeutic. Specific aims of this study are: 1. Determine the maximum
tolerated dose of capsules containing 500mg of freeze-dried noni fruit extract. 2. Define
toxicities associated with the ingestion of noni. 3. Collect preliminary information on the
efficacy of noni in respect to anti-tumor and symptom control properties to help select
specific patients for subsequent Phase II studies. 4. Identify chemical constituents of the
extract that can be used to characterize the bioavailability and pharmacokinetics of noni
food supplement.