Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Behnam Daheshpour Charity Organization, Tehran, Iran | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin plus RT | Experimental | 120mg/day nanocurcumin during RT course |
|
| Placebo plus RT | Placebo Comparator | 120mg/day placebo of nanocurcumin during RT course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug | 120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abolfazl Razzaghdoust | Shahid Beheshti University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shohada-e-Tajrish Medical Center | Tehran | Iran |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RT | Radiation | EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT |
|
|
| Placebo | Drug | Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy |
|
|
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |