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Study of Noni in Cancer Patients
This study is currently recruiting patients.
Verified by National Center for Complementary and Alternative Medicine (NCCAM) March 2006
Purpose
The purpose of this Phase 1 study is to: 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 2 studies, 4. identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.
| Condition |
Intervention |
Phase |
Neoplasms
Neoplasm Metastasis
|
Drug: Noni Extract
|
Phase I
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MedlinePlus related topics: Cancer; Cancer Alternative Therapies
Genetics Home Reference related topics: Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Noni in Cancer Patients
Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):
Study start: November 2001; Expected completion: June 2006
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.
Eligibility
Genders Eligible for Study: Both
Criteria
Patients must:
- Have a pathologically or cytologically verified diagnosis of cancer and evidence of disease for which no standard treatment is available;
- Be ambulatory, capable of self care, and up and about more than 50% of waking hours;
- Have completed all other cancer treatments at least four weeks previously;
- Have been on any medications considered by their physician to be essential to their health (e.g. lipid lowering, antidiabetic , antihypertensive) at consistent dosing at least four weeks prior to starting noni;
- 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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00033878
Hawaii
University of Hawaii, Cancer Research Center, Honolulu, Hawaii, 96813, United States; Recruiting
Study chairs or principal investigators
Brian F. Issell, MD, FRACP, Principal Investigator, University of Hawaii
More Information
Study ID Numbers: 1 R21 AT00896-01
Last Updated: March 9, 2006
Record first received: April 11, 2002
ClinicalTrials.gov Identifier: NCT00033878
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-07-13
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