Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Radiation Therapy; Prostate Cancer

Treatments: Dietary Supplement: Curcumin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01917890

Radiation Therapy And Curcumin

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Curcumin Group

Experimental group

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)

Treatment:

Dietary Supplement: Curcumin

Placebo

Placebo Comparator group

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)

Treatment:

Dietary Supplement: Placebo