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Prostate cancer is the second most incident cancer among male population worldwide. Radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin Group | Experimental | Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of curcumin (as 6 capsules 500 mg) |
|
| Placebo | Placebo Comparator | Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of placebo (as 6 capsules 500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Dietary Supplement | Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of BCM95 Curcumin (as 6 × 500 mg capsules) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical or clinical progression-free survival | To assess this outcome the results of magnetic resonance spectroscopy (MRS)will be compared between the 2 groups 1 week before radiation therapy and 3 months after radiotherapy completion. Also prostate specific antigen (PSA)rebound will be compared between the 2 groups after 1 year. Side effects of treatment during 1 year after treatment completion will be compared between the 2 groups using questionnaires and physical examination | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life related issues will be compared between the 2 groups 1 week before radiotherapy onset and 3 months and 1 year after radiotherapy completion using EORTC QLQ-C30 and EORTC QLQ - PR25 | 1 year |
| Sexual dysfunction score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Rastmanesh, PhD | Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences, | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology and radiotherapy department, Besat Hospital | Tehran | Tehran Province | 556432412 | Iran |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
| Placebo | Dietary Supplement | Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of roasted rice powder (as 6 × 500 mg capsules) |
|
Sexual dysfunction score will be compared between the 2 groups 1 week before radiotherapy onset and 3 months and 1 year after radiotherapy completion using EORTC QLQ - PR25
| 1 year |
| C-reactive protein (hs-CRP) | It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L) | 5 months |
| Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6)) | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml) | 5 monthes |
| Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX)) | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L) | 5 months |
| cycloxygenase 2 (COX2) | measuring activity and gene expression of the enzyme in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy. | 5 months |
| Nuclear factor KB (NF-ΚB) | measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy. | 5 months |
| 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 |