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Noni

Noni Extract

Brian F. Issell, MD, FRACP

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.

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 of Noni in Cancer Patients

Phase I Study of Noni in Cancer Patients

National Center for Complementary and Integrative Health (NCCIH)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)

Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.

Noni extract

Jeffrey Huang, PharmD

The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with very low risk or low risk prostate cancer

Efficacy and safety of Noni extract will be assessed in an estimated sample size of 30 subjects. Efficacy will be measured by the induction of favorable gene expression changes on Oncotype Dx Prostate Cancer Test after 12 months of intervention with Noni extract (6,000 mg/day). Other efficacy endpoints include the incidence of tumor progression after 12 months of intervention with Noni extract and serum PSA doubling time. Safety measurements will include the incidence and severity of adverse events, effects on angiogenesis (CD34), cell proliferation (Ki-67), and apoptosis (TUNEL) in prostate tissue biopsy samples from Month 12

Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer

Phase II Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer

Exploring gene expression changes on Oncotype DX Genomic Prostate Score (GPS). The Oncotype DX assay is a clinically validated 17-gene genomic assay that provides a genomic prostate score (GPS; scale 0-100) measuring the heterogeneous nature of prostate tumors. A higher score means a higher risk of disease. Unfortunately, Genomic Health was unable to run the assay on 12-month prostate biopsy samples in which active cancer was not identified therefore we only have baseline data.

Measure tumor size at screening and compare after 12 months of study participation. Disease progression will be identified by either an increase in Gleason score, increase in positive cores, and/or an increase in tumor volume.

Comparing the serum Prostate Specific Antigen (PSA) test levels for the duration of the trial in men diagnosed with very low risk or low risk prostate cancer. Measure the duration of time it takes for a subjects Prostate specific antigen level to double.

Tolerability of Noni extract in men diagnosed with very low risk or low risk prostate cancer as assessed by CTCAE v4.0

Utilizing prostate tissue biopsy samples and serum blood plasma from participants prior to receiving noni extract and after the subject completes 12 months of receiving noni extract. Apoptosis was quantified based on caspase-3 immunostaining. Proliferation was quantified based on Ki-67 immunostaining.

Utilizing prostate tissue biopsy samples and serum blood plasma from participants prior to receiving noni extract and after the subject completes 12 months of receiving noni extract. MVD, a surrogate for angiogenesis, was quantified based on CD-31 immunostaining.

University of Hawaii Cancer Research Center

University of Hawaii

Noni extract 6,000 mg/day (4 capsules, 3 times per day)

Noni extract: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.

Noni 6,000 mg/Day

Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)

Noni extract: Intervention will be administered on an outpatient basis. Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Stacy Mercado, IIT/ Education Manager

GPS Pt 1 Baseline

GPS Pt 2 Baseline

GPS Pt 3 Baseline

GPS Pt 4 Baseline

GPS Pt 5 Baseline

GPS Pt 6 Baseline

Compare Genomic Prostate Score (GPS) in Prostatic Tumors

Positive Cores pre therapy Pt 1

Positive Core post therapy Pt 1

Positive Cores pre therapy Pt 2

Positive Cores post therapy Pt 2

Positive Cores pre therapy Pt 3

Positive Cores post therapy Pt 3

Positive Cores pre therapy Pt 4

Positive Cores post therapy Pt 4

Positive Cores pre therapy Pt 5

Positive Cores post therapy Pt 5

Positive Cores pre therapy Pt 6

Positive Cores post therapy Pt 6

Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer

PSA Baseline Pt 1

PSA Baseline Pt 2

PSA Baseline Pt 3

PSA Baseline Pt 4

PSA Baseline Pt 5

PSA Baseline Pt 6

PSA 9 Month Pt 1

PSA 9 Month Pt 2

PSA 9 Month Pt 3

PSA 9 Month Pt 4

PSA 9 Month Pt 5

PSA 9 Month Pt 6

Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels

Frequency of Adverse Events

Apoptosis Pre Treatment

Proliferation Pre Treatment

Apoptosis Post Treatment

Proliferation Post Treatment

Explore the Molecular Pathways Contributing to the Activities Associated With Noni Extract in the Prostate Cancer (e.g. Cell Proliferation, and Apoptosis in Prostate Tissue Biopsy Samples) Via Immunohistochemistry (IHC) Staining.

MVD Pre Treatment

MVD Post Treatment

Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)

Noni extract: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.

Explore the Molecular Pathways Contributing to the Activities Associated With Noni Extract in the Prostate Cancer (e.g., Angiogenesis) in Prostate Tissue Biopsy Samples) Via Immunohistochemistry (IHC) Staining.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Noni in Cancer Patients	NCT00033878	Neoplasms Neoplasm Metast...	Noni Extract	-	National Center for Complementary and Integrative Health (NCCIH)
Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer	NCT02648919	Prostate Cancer	Noni extract	55 Years -	University of Hawaii

Spots Global Cancer Trial Database for noni extract

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