Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Radiation Therapy
• Intervention / Treatment: Dietary supplement: Curcumin; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 556432412
    • Oncology and radiotherapy department, Besat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin Group; 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)	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); Other Names: turmeric pigment
Placebo Comparator: 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)	Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Chair: Reza Rastmanesh, PhD, Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 3, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: curcumin; radioprotective; radiosensitizer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: Radiation Therapy And Curcumin