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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation Therapy Dietary Supplement: Curcumin Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer
Study Start Date : March 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Curcumin

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 Name: 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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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. 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)

  6. 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.

  7. 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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917890


Locations
Iran, Islamic Republic of
Oncology and radiotherapy department, Besat Hospital
Tehran, Iran, Islamic Republic of, 556432412
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Study Chair: Reza Rastmanesh, PhD Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,

Responsible Party: Reza Rastmanesh, Dr., Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01917890     History of Changes
Other Study ID Numbers: Radiation Therapy And Curcumin
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Reza Rastmanesh, Shahid Beheshti University of Medical Sciences:
curcumin
radioprotective
radiosensitizer

Additional relevant MeSH terms:
Curcumin
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action