Study of Noni in Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00033878
First received: April 11, 2002
Last updated: March 27, 2007
Last verified: March 2007

April 11, 2002
March 27, 2007
November 2001
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Complete list of historical versions of study NCT00033878 on ClinicalTrials.gov Archive Site
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Study of Noni in Cancer Patients
Phase I Study of Noni in Cancer Patients

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Neoplasms
  • Neoplasm Metastasis
Drug: Noni Extract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2006
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033878
R21 AT000896-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Brian F. Issell, MD, FRACP University of Hawaii
National Center for Complementary and Alternative Medicine (NCCAM)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP