Clinical trial NCT01917890: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Radiation Therapy
Keywords: curcumin
radioprotective
radiosensitizer
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Biochemical or clinical progression-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: Sexual dysfunction score
timeFrame: 1 year
measure: C-reactive protein (hs-CRP)
timeFrame: 5 months
measure: Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))
timeFrame: 5 monthes
measure: Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))
timeFrame: 5 months
measure: cycloxygenase 2 (COX2)
timeFrame: 5 months
measure: Nuclear factor KB (NF-ΚB)
timeFrame: 5 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Oncology and radiotherapy department, Besat Hospital
Study officials:
affiliation: Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,
name: Reza Rastmanesh, PhD
role: STUDY_CHAIR
References: