Spots Global Cancer Trial Database for Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
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Trial Identification
Brief Title: Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
Official Title: Phase II Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
Study ID: NCT02648919
Conditions
Interventions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Contact Details
Name: Jeffrey Huang, PharmD
Affiliation: Faculty
Role: PRINCIPAL_INVESTIGATOR
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