Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033878
Status:
COMPLETED
Last Update Posted:
2007-03-28
First Post:
2002-04-11
Brief Title:
Study of Noni in Cancer Patients
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Phase I Study of Noni in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 supplements 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None