Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02724618
• Other study ID #: 406
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 9, 2016
• Last updated: October 11, 2017
• Start date: March 2016
• Est. completion date: April 2022

Study information

• Verified date: April 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: April 2022
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

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

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shohada-e-Tajrish Medical Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences	Behnam Daheshpour Charity Organization, Tehran, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]	Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)	90 days
Secondary	Cystitis [assessed using CTCAE Grading Criteria]	Cystitis as assessed using CTCAE Grading Criteria	90 days
Secondary	Hematologic Toxicity	Hematologic Toxicity as assessed by significant reduction in hematologic components	90 days
Secondary	Biochemical progression-free survival (b-PFS)	b-PFS as assessed using Prostate-Specific Antigen (PSA)	5-years
Secondary	Treatment Response	Treatment Response as assessed using Magnetic Resonance Imaging techniques	3 months after treatment termination