NCT02648919

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-01-07
• Last updated: 2021-11-26
• Results posted: 2021-11-26

Locations

1 site across 1 country: United States