Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917890
• Other study ID #: Radiation Therapy And Curcumin
• Status: Completed
• Phase: N/A
• First received: August 3, 2013
• Last updated: November 16, 2015
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2015
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: National Nutrition and Food Technology Research Inistitute
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiation Therapy

Intervention

Dietary Supplement:
• Curcumin
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)
• Placebo
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)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Oncology and radiotherapy department, Besat Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Sexual dysfunction score	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Nuclear factor KB (NF-?B)	measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy.	5 months	No