Trial | NCT02724618  Report issue

Title

Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)
Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    curcumin ...

  • Study Participants

    64
There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.
Study Started
Mar 31
2016
Primary Completion
Apr 15
2017
Study Completion
Apr 30
2022
Anticipated
Last Update
Oct 12
2017

Drug Curcumin

120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy

  • Other names: SinaCurcumin®

Radiation RT

EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT

  • Other names: External Beam Radiation Therapy (EBRT)

Drug Placebo

Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy

  • Other names: SinaCurcumin® placebo

Curcumin plus RT Experimental

120mg/day nanocurcumin during RT course

Placebo plus RT Placebo Comparator

120mg/day placebo of nanocurcumin during RT course

Criteria 

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Candidate for External Beam Radiotherapy
ECOG performance status 0-2

Exclusion Criteria:

Patients with Metastatic Prostate Cancer
Patients with Kidney & Liver dysfunction
Gastrointestinal disorders such as IBD, reflux and peptic ulcers
Any adverse reaction to curcumin
No Results Posted