- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033878
Study of Noni in Cancer Patients
March 27, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- University of Hawaii, Cancer Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian F. Issell, MD, FRACP, University of Hawaii
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
April 11, 2002
First Submitted That Met QC Criteria
April 11, 2002
First Posted (Estimate)
April 12, 2002
Study Record Updates
Last Update Posted (Estimate)
March 28, 2007
Last Update Submitted That Met QC Criteria
March 27, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000896-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
-
GlaxoSmithKlineRecruitingColonic Neoplasms | Neoplasms, ColonUnited States, Finland, France, Italy, Japan, Netherlands, Norway, Spain, Taiwan, United Kingdom, Australia, Belgium, Brazil, Germany, Greece, Sweden, Turkey, Canada, Korea, Republic of, Argentina, Hungary, Estonia, Portugal, Mexico, Pa...
-
GlaxoSmithKlineCompleted
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaCompletedUterine Neoplasms | Prostatic Neoplasms | Cervix Neoplasms | Bladder NeoplasmsCanada
-
N.N. Petrov National Medical Research Center of...Active, not recruitingColonic Neoplasms MalignantRussian Federation
-
Peking University First HospitalShengli Oilfield Hospital; The Second Affiliated Hospital of Baotou Medical...Enrolling by invitationRectal Neoplasms MalignantChina
-
Cancer Institute and Hospital, Chinese Academy...CompletedRectal Neoplasms MalignantChina
-
Seattle Children's HospitalSuspendedNeoplasms, Benign | Neoplasms, MalignantUnited States
-
European Association for Endoscopic SurgeryWithdrawn
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
Clinical Trials on Noni Extract
-
University of HawaiiUniversity of Hawaii Cancer Research CenterTerminatedProstate CancerUnited States
-
Tahitian Noni International, Inc.University of Illinois at ChicagoCompletedDNA DamageUnited States
-
University of Illinois at ChicagoExcellence in Academic Medicine (EAM) GrantCompleted
-
Tahitian Noni International, Inc.TNO-BIBRACompleted
-
University Hospitals Cleveland Medical CenterUnknownAsthma | Allergic Rhinitis | Allergic ConjunctivitisUnited States
-
Access Business GroupCompleted
-
National Institute of Allergy and Infectious Diseases...Inner-City Asthma ConsortiumCompletedAsthma | Perennial Allergic RhinitisUnited States
-
SeppicCompleted
-
Mahidol UniversityCompleted
-
Unilever R&DCompleted