Phase I Study of Noni in Cancer Patients
Study of Noni in Cancer Patients
Sponsors
Source
National Center for Complementary and Integrative Health (NCCIH)
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.
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.
Overall Status
Completed
Start Date
2001-11-01
Completion Date
2006-06-01
Primary Completion Date
N/A
Phase
Phase 1
Study Type
Interventional
Conditions
Intervention
Eligibility
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.
Gender
All
Minimum Age
N/A
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Brian F. Issell, MD, FRACP |
Principal Investigator |
University of Hawaii |
Location
Facility |
|
University of Hawaii, Cancer Research Center Honolulu Hawaii 96813 United States |
Location Countries
Country
United States
Verification Date
2007-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keyword
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Nct Alias
NCT00060060
Firstreceived Results Disposition Date
N/A
Study Design Info
Primary Purpose
Treatment
Study First Submitted
April 11, 2002
Study First Submitted Qc
April 11, 2002
Study First Posted
April 12, 2002
Last Update Submitted
March 27, 2007
Last Update Submitted Qc
March 27, 2007
Last Update Posted
March 28, 2007
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.