Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

October 11, 2017 updated by: Bahram Mofid, Shahid Beheshti University of Medical Sciences

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Curcumin plus RT
120mg/day nanocurcumin during RT course
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)
PLACEBO_COMPARATOR: Placebo plus RT
120mg/day placebo of nanocurcumin during RT course
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
Time Frame: 90 days
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cystitis [assessed using CTCAE Grading Criteria]
Time Frame: 90 days
Cystitis as assessed using CTCAE Grading Criteria
90 days
Hematologic Toxicity
Time Frame: 90 days
Hematologic Toxicity as assessed by significant reduction in hematologic components
90 days
Biochemical progression-free survival (b-PFS)
Time Frame: 5-years
b-PFS as assessed using Prostate-Specific Antigen (PSA)
5-years
Treatment Response
Time Frame: 3 months after treatment termination
Treatment Response as assessed using Magnetic Resonance Imaging techniques
3 months after treatment termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Behnam Daheshpour Charity Organization, Tehran, Iran

Investigators

  • Study Director: Abolfazl Razzaghdoust, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

April 15, 2017

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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