The Noni Study

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. 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@...