Back to results

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Primary Purpose

Prostate Cancer, Radiation Therapy

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Curcumin

Placebo

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring curcumin, radioprotective, radiosensitizer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Oncology and radiotherapy department, Besat Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin Group

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life

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

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)

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))

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))

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)

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)

measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy.

Full Information

NCT ID

NCT01917890

First Posted

August 3, 2013

Last Updated

November 16, 2015

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01917890

Brief Title

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Official Title

Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Radiation Therapy

Keywords

curcumin, radioprotective, radiosensitizer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin Group

Arm Type

Experimental

Arm Description

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)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Dietary Supplement

Intervention Name(s)

Curcumin

Other Intervention Name(s)

turmeric pigment

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Biochemical or clinical progression-free survival

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Quality of life

Description

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

Time Frame

1 year

Title

Sexual dysfunction score

Description

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

Time Frame

1 year

Title

C-reactive protein (hs-CRP)

Description

It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L)

Time Frame

5 months

Title

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

Description

They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml)

Time Frame

5 monthes

Title

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

Description

They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L)

Time Frame

5 months

Title

cycloxygenase 2 (COX2)

Description

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.

Time Frame

5 months

Title

Nuclear factor KB (NF-ΚB)

Description

measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy.

Time Frame

5 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Rastmanesh, PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Oncology and radiotherapy department, Besat Hospital

City

Tehran

ZIP/Postal Code

556432412

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

We'll reach out to this number within 24 hrs