Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

November 16, 2015 updated by: Reza Rastmanesh, Shahid Beheshti University of Medical Sciences

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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
1 year
Sexual dysfunction score
Time Frame: 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
1 year
C-reactive protein (hs-CRP)
Time Frame: 5 months
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))
Time Frame: 5 monthes
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))
Time Frame: 5 months
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)
Time Frame: 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.
5 months
Nuclear factor KB (NF-ΚB)
Time Frame: 5 months
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Radiation Therapy And Curcumin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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