Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Study Overview
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Curcumin
* Radiation: RT
* Drug: Placebo


Participation Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin plus RT<br>120mg/day nanocurcumin during RT course | Drug: Curcumin<br>* 120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy<br>* Other names: SinaCurcumin®;Radiation: RT<br>* EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT<br>* Other names: External Beam Radiation Therapy (EBRT);|
| Placebo Comparator: Placebo plus RT<br>120mg/day placebo of nanocurcumin during RT course | Radiation: RT<br>* EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT<br>* Other names: External Beam Radiation Therapy (EBRT);Drug: Placebo<br>* Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy<br>* Other names: SinaCurcumin® placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)] | Proctitis as assessed using Common terminology criteria for adverse events (CTCAE) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystitis [assessed using CTCAE Grading Criteria] | Cystitis as assessed using CTCAE Grading Criteria | 90 days | 
| Hematologic Toxicity | Hematologic Toxicity as assessed by significant reduction in hematologic components | 90 days | 
| Biochemical progression-free survival (b-PFS) | b-PFS as assessed using Prostate-Specific Antigen (PSA) | 5-years | 
| Treatment Response | Treatment Response as assessed using Magnetic Resonance Imaging techniques | 3 months after treatment termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer