Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

NCT01917890 | Completed DMC

• 1 other identifier: Radiation Therapy And Curcumin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Radiation Therapy

Keywords

curcumin; radioprotective; radiosensitizer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of life

  1 year

• Sexual dysfunction score

  1 year

• C-reactive protein (hs-CRP)

  5 months

• Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))

  5 monthes

• Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))

  5 months

Study Arms (2)

Curcumin Group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Curcumin DIETARY_SUPPLEMENT

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)

Also known as: turmeric pigment

Curcumin Group

Placebo DIETARY_SUPPLEMENT

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)

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Age range of 50-80
• ECOG performance status 0-1
• Life expectancy \> 5 years
• Must be enrolled in a social security program
• No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
• No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg)
• No contraindication to luteinizing hormone-releasing hormone agonists
• No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
• No hip prosthesis
• Must not be deprived of liberty or under guardianship
• No geographical, social, or psychological reasons that would preclude follow up

You may not qualify if:

• Clinical stage T3 or T4
• Gleason score ≥ 8
• Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL
• other prior surgery for prostate cancer
• concurrent participation in another clinical trial which would require approval upon entry to this trial
• Gastrointestinal disorders such as IBD, reflux and peptic ulcers
• Any adverse reaction to curcumin

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Oncology and radiotherapy department, Besat Hospital

Tehran, Tehran Province, 556432412, Iran

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Reza Rastmanesh, PhD

  Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 3, 2013
• First Posted: August 7, 2013
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

IR (1)