This Phase I study of noni in cancer patients represents a firstThe Noni Fruit step in the systematic study of Complementary and Alternative Medicine (CAM) practicesthat draw on Asian and Pacific Island cultural traditionsof healing to control cancer and its related symptoms. It is being supported by a $170, 000 grant over two years from the National Institutes of Health (R21 AT00896). The Principal Investigator is Brian F. Issell, M.D.
Noni, extracted from Morinda citrifolia 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 many 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.

Eligibility criteria for the study are:

1. Patients must have a pathologically or cytologically verified diagnosis of cancer and evidence of disease for which no standard treatment is available.
   
2. Patients must be ambulatory, capable of self care, and up and about more than 50% of waking hours (Zubrod Performance Status 0-2)
   
3. Patients should have completed all other cancer treatments at least four weeks previously.
   
4. If patients are taking medications that are considered by their allopathic practitioner to be essential for their health (e.g. antidiabetic, antihypertensive, lipid lowering), they must have been on these medications at consistent dosing for at least four weeks prior to starting noni.
   
5. Patients must agree to take no other CAM treatments while taking noni.and agree to keep a diary, recording all medications taken daily, including all non prescription products and to record the time that noni is taken.
   

Enquiries: For more information about the study, please contact:

Faith Inoshita, R.N., M.S.
Clinical Research Nurse
(808)586-2979
email: faithi@crch.hawaii.edu

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