Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

NCT ID: NCT02724618

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Curcumin Protection, Radiation Controlled Clinical Trials, Randomized Radiation Therapy Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Curcumin plus RT

120mg/day nanocurcumin during RT course

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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

RT

Intervention Type RADIATION

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

Placebo plus RT

120mg/day placebo of nanocurcumin during RT course

Group Type PLACEBO_COMPARATOR

RT

Intervention Type RADIATION

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

Placebo

Intervention Type DRUG

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

Interventions

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Curcumin

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

Intervention Type DRUG

RT

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

Intervention Type RADIATION

Placebo

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

Intervention Type DRUG

Other Intervention Names

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SinaCurcumin® External Beam Radiation Therapy (EBRT) SinaCurcumin® placebo

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Behnam Daheshpour Charity Organization, Tehran, Iran

UNKNOWN

Sponsor Role collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Bahram Mofid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abolfazl Razzaghdoust

Role: STUDY_DIRECTOR

Shahid Beheshti University of Medical Sciences

Locations

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Shohada-e-Tajrish Medical Center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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406

Identifier Type: -

Identifier Source: org_study_id