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Trial record 4 of 158 for:    Enzyme | curcumin

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01917890
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Reza Rastmanesh, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 3, 2013
First Posted Date  ICMJE August 7, 2013
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01917890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer
Official Title  ICMJE Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostate Cancer
  • Radiation Therapy
Intervention  ICMJE
  • 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 Name: turmeric pigment
  • 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)

Study Arms  ICMJE
  • 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)

    Intervention: Dietary Supplement: Curcumin
  • 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)

    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01917890
Other Study ID Numbers  ICMJE Radiation Therapy And Curcumin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reza Rastmanesh, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Reza Rastmanesh, PhD Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP