NCT00033878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2002

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 28, 2007

Status Verified

March 1, 2007

First QC Date

April 11, 2002

Last Update Submit

March 27, 2007

Conditions

NeoplasmsNeoplasm Metastasis

Keywords

Advanced Cancer

Interventions

Noni ExtractDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii, Cancer Research Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian F. Issell, MD, FRACP

    University of Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 11, 2002

First Posted

April 12, 2002

Study Start

November 1, 2001

Study Completion

June 1, 2006

Last Updated

March 28, 2007

Record last verified: 2007-03

Locations

US(1)