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Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02724618
Collaborator
Behnam Daheshpour Charity Organization, Tehran, Iran (Other)
64
Enrollment
1
Location
2
Arms
73
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Mar 1, 2016
Actual Primary Completion Date :
Apr 15, 2017
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)] [90 days]

      Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)

    Secondary Outcome Measures

    1. Cystitis [assessed using CTCAE Grading Criteria] [90 days]

      Cystitis as assessed using CTCAE Grading Criteria

    2. Hematologic Toxicity [90 days]

      Hematologic Toxicity as assessed by significant reduction in hematologic components

    3. Biochemical progression-free survival (b-PFS) [5-years]

      b-PFS as assessed using Prostate-Specific Antigen (PSA)

    4. Treatment Response [3 months after treatment termination]

      Treatment Response as assessed using Magnetic Resonance Imaging techniques

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bahram Mofid, Professor, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02724618
    Other Study ID Numbers:
    • 406
    First Posted:
    Mar 31, 2016
    Last Update Posted:
    Oct 12, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Bahram Mofid, Professor, Shahid Beheshti University of Medical Sciences
    Curcumin
    Protection, Radiation
    Controlled Clinical Trials, Randomized
    Radiation Therapy
    Prostate Cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Curcumin

    Study Results

    No Results Posted as of Oct 12, 2017