Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer; Radiation Therapy
• Interventions: Dietary Supplement: Curcumin; Dietary Supplement: Placebo

• Registration Number: NCT01917890
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the prostate
2. Age range of 50-80
3. ECOG performance status 0-1
4. Life expectancy > 5 years
5. Must be enrolled in a social security program
6. No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
7. No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg)
8. No contraindication to luteinizing hormone-releasing hormone agonists
9. No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
10. No hip prosthesis
11. Must not be deprived of liberty or under guardianship
12. No geographical, social, or psychological reasons that would preclude follow up

Exclusion Criteria

1. Clinical stage T3 or T4
2. Gleason score ≥ 8
3. Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL
4. other prior surgery for prostate cancer
5. concurrent participation in another clinical trial which would require approval upon entry to this trial
6. Gastrointestinal disorders such as IBD, reflux and peptic ulcers
7. Any adverse reaction to curcumin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin Group	Curcumin	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	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)

Primary Outcome Measures

Name	Time	Method
Biochemical or clinical progression-free survival	1 year	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

Secondary Outcome Measures

Name	Time	Method
Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))	5 monthes	They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml)
cycloxygenase 2 (COX2)	5 months	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.
Nuclear factor KB (NF-ΚB)	5 months	measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy.
Sexual dysfunction score	1 year	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
Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))	5 months	They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L)
Quality of life	1 year	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
C-reactive protein (hs-CRP)	5 months	It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L)

Trial Locations

Locations (1)

Oncology and radiotherapy department, Besat Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of