Prostate CancerNCT01917890
Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer
A study testing Curcumin in people with Prostate Cancer and Radiation Therapy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Radiation Therapy
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Oncology and radiotherapy department, Besat Hospital
Tehran, Tehran Province, 556432412
About this study
Official title: Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer
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
- Being tested
- Curcumin, Placebo
- Keywords
- curcumin, radioprotective, radiosensitizer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called turmeric pigment
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)
PlaceboDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
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
Measured: 1 year
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
Measured: 1 year
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)
Measured: 5 months
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)
Measured: 5 monthes
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)
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Rastmanesh, Shahid Beheshti University of Medical Sciences
- Investigators
- Reza Rastmanesh, PhD, Study chair, Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917890
- Sponsor's protocol ID
- Radiation Therapy And Curcumin
- Status last verified
- Nov 2015
- First submitted
- 3 Aug 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01917890
- Acronym / sponsor ID
- Radiation Therapy And Curcumin
- Conditions
- Prostate Cancer, Radiation Therapy
- Keywords
- curcumin, radioprotective, radiosensitizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin Group | Experimental | Dietary Supplement: CurcuminPatients 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) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients 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) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: turmeric pigmentPatients 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) | Dietary supplement | Curcumin Group |
| PlaceboPatients 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) | Dietary supplement | Placebo |
Primary outcome
Biochemical or clinical progression-free survival
Time frame: 1 year
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
7 secondary outcomes
Quality of life
Time frame: 1 year
Sexual dysfunction score
Time frame: 1 year
C-reactive protein (hs-CRP)
Time frame: 5 months
Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))
Time frame: 5 monthes
Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))
Time frame: 5 months
cycloxygenase 2 (COX2)
Time frame: 5 months
Nuclear factor KB (NF-ΚB)
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Rastmanesh, PhD study chair
Clinical Nutrition & Dietetics Dept., Shahid Beheshti University of Medical Sciences,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Prostate Cancer and Radiation Therapy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical or clinical progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.