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Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

NCT ID: NCT01917890

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Prostate Cancer Radiation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Curcumin

Intervention Type 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)

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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turmeric pigment

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Rastmanesh

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Rastmanesh, PhD

Role: STUDY_CHAIR

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

Locations

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Oncology and radiotherapy department, Besat Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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Radiation Therapy And Curcumin

Identifier Type: -

Identifier Source: org_study_id