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Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724618
Recruitment Status : Unknown
Verified April 2017 by Bahram Mofid, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Behnam Daheshpour Charity Organization, Tehran, Iran
Information provided by (Responsible Party):
Bahram Mofid, Shahid Beheshti University of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Curcumin Radiation: RT Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
Actual Study Start Date : March 2016
Actual Primary Completion Date : April 15, 2017
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Curcumin

Arms and Interventions
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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 Name: SinaCurcumin®

Radiation: RT
EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT
Other Name: 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 Name: External Beam Radiation Therapy (EBRT)

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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Cystitis [assessed using CTCAE Grading Criteria] [ Time Frame: 90 days ]
    Cystitis as assessed using CTCAE Grading Criteria

  2. Hematologic Toxicity [ Time Frame: 90 days ]
    Hematologic Toxicity as assessed by significant reduction in hematologic components

  3. Biochemical progression-free survival (b-PFS) [ Time Frame: 5-years ]
    b-PFS as assessed using Prostate-Specific Antigen (PSA)

  4. Treatment Response [ Time Frame: 3 months after treatment termination ]
    Treatment Response as assessed using Magnetic Resonance Imaging techniques


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724618


Locations
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Iran, Islamic Republic of
Shohada-e-Tajrish Medical Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Behnam Daheshpour Charity Organization, Tehran, Iran
Investigators
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Study Director: Abolfazl Razzaghdoust Shahid Beheshti University of Medical Sciences
More Information
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Responsible Party: Bahram Mofid, Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02724618    
Other Study ID Numbers: 406
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bahram Mofid, Shahid Beheshti University of Medical Sciences:
Curcumin
Protection, Radiation
Controlled Clinical Trials, Randomized
Radiation Therapy
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Curcumin
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action