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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
64
120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy
EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT
Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy
Shohada-e-Tajrish Medical Center
Tehran, Iran
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
Time frame: 90 days
Cystitis [assessed using CTCAE Grading Criteria]
Cystitis as assessed using CTCAE Grading Criteria
Time frame: 90 days
Hematologic Toxicity
Hematologic Toxicity as assessed by significant reduction in hematologic components
Time frame: 90 days
Biochemical progression-free survival (b-PFS)
b-PFS as assessed using Prostate-Specific Antigen (PSA)
Time frame: 5-years
Treatment Response
Treatment Response as assessed using Magnetic Resonance Imaging techniques
Time frame: 3 months after treatment termination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.