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Study of Noni in Cancer Patients

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ClinicalTrials.gov Identifier: NCT00033878
Recruitment Status : Completed
First Posted : April 12, 2002
Last Update Posted : March 28, 2007
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Neoplasm Metastasis Drug: Noni Extract Phase 1

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of Noni in Cancer Patients
Study Start Date : November 2001
Actual Study Completion Date : June 2006
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033878


Locations
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United States, Hawaii
University of Hawaii, Cancer Research Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Brian F. Issell, MD, FRACP University of Hawaii
More Information
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ClinicalTrials.gov Identifier: NCT00033878    
Obsolete Identifiers: NCT00060060
Other Study ID Numbers: R21AT000896-01 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2002    Key Record Dates
Last Update Posted: March 28, 2007
Last Verified: March 2007
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Advanced Cancer
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes