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Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Curcumin
RT
Placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shohada-e-Tajrish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin plus RT

Placebo plus RT

Arm Description

120mg/day nanocurcumin during RT course

120mg/day placebo of nanocurcumin during RT course

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cystitis [assessed using CTCAE Grading Criteria]
Cystitis as assessed using CTCAE Grading Criteria
Hematologic Toxicity
Hematologic Toxicity as assessed by significant reduction in hematologic components
Biochemical progression-free survival (b-PFS)
b-PFS as assessed using Prostate-Specific Antigen (PSA)
Treatment Response
Treatment Response as assessed using Magnetic Resonance Imaging techniques

Full Information

First Posted
March 9, 2016
Last Updated
October 11, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Behnam Daheshpour Charity Organization, Tehran, Iran
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1. Study Identification

Unique Protocol Identification Number
NCT02724618
Brief Title
Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)
Official Title
Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Behnam Daheshpour Charity Organization, Tehran, Iran

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curcumin plus RT
Arm Type
Experimental
Arm Description
120mg/day nanocurcumin during RT course
Arm Title
Placebo plus RT
Arm Type
Placebo Comparator
Arm Description
120mg/day placebo of nanocurcumin during RT course
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
SinaCurcumin®
Intervention Description
120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy
Intervention Type
Radiation
Intervention Name(s)
RT
Other Intervention Name(s)
External Beam Radiation Therapy (EBRT)
Intervention Description
EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
SinaCurcumin® placebo
Intervention Description
Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy
Primary Outcome Measure Information:
Title
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
Description
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cystitis [assessed using CTCAE Grading Criteria]
Description
Cystitis as assessed using CTCAE Grading Criteria
Time Frame
90 days
Title
Hematologic Toxicity
Description
Hematologic Toxicity as assessed by significant reduction in hematologic components
Time Frame
90 days
Title
Biochemical progression-free survival (b-PFS)
Description
b-PFS as assessed using Prostate-Specific Antigen (PSA)
Time Frame
5-years
Title
Treatment Response
Description
Treatment Response as assessed using Magnetic Resonance Imaging techniques
Time Frame
3 months after treatment termination

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abolfazl Razzaghdoust
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Shohada-e-Tajrish Medical Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

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