Prostate CancerPhase 2NCT02724618
Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)
A Phase 2 study testing Curcumin and RT in people with Prostate Cancer, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Curcumin and RT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIran
- Study dates
- Mar 2016to Apr 2022
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Candidate for External Beam Radiotherapy
- ECOG performance status 0-2
Who cannot join
- Patients with Metastatic Prostate Cancer
- Patients with Kidney \& Liver dysfunction
- Gastrointestinal disorders such as IBD, reflux and peptic ulcers
- Any adverse reaction to curcumin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.
- Conditions
- Prostate Cancer
- Being tested
- Curcumin, RT, Placebo
- Keywords
- Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called SinaCurcumin®
120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy
RTRadiation
Also called External Beam Radiation Therapy (EBRT)
EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT
PlaceboDrug
Also called SinaCurcumin® placebo
Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Curcumin plus RT | Experimental | 120mg/day nanocurcumin during RT course Receives: Drug: Curcumin; Radiation: RT |
| Placebo plus RT | Placebo comparator | 120mg/day placebo of nanocurcumin during RT course Receives: Radiation: RT; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
Measured: 90 days
Secondary outcomes (4)
Cystitis [assessed using CTCAE Grading Criteria]
Cystitis as assessed using CTCAE Grading Criteria
Measured: 90 days
Hematologic Toxicity
Hematologic Toxicity as assessed by significant reduction in hematologic components
Measured: 90 days
Biochemical progression-free survival (b-PFS)
b-PFS as assessed using Prostate-Specific Antigen (PSA)
Measured: 5-years
Treatment Response
Treatment Response as assessed using Magnetic Resonance Imaging techniques
Measured: 3 months after treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion15 Apr 2017
- Study completionApr 2022 (estimated)
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Behnam Daheshpour Charity Organization, Tehran, Iran
- Responsible party
- Principal investigator, Bahram Mofid, Shahid Beheshti University of Medical Sciences
- Investigators
- Abolfazl Razzaghdoust, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724618
- Sponsor's protocol ID
- 406
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02724618
- Acronym / sponsor ID
- 406
- Conditions
- Prostate Cancer
- Keywords
- Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Behnam Daheshpour Charity Organization, Tehran, Iran
- Study start
- Mar 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- Apr 2022 (estimated)
- First posted
- 31 Mar 2016 (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.
There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin plus RT | Experimental | Drug: Curcumin, Radiation: RT120mg/day nanocurcumin during RT course |
| Placebo plus RT | Placebo comparator | Radiation: RT, Drug: Placebo120mg/day placebo of nanocurcumin during RT course |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Candidate for External Beam Radiotherapy
- ECOG performance status 0-2
Key exclusion criteria (4 listed)
- Patients with Metastatic Prostate Cancer
- Patients with Kidney \& Liver dysfunction
- Gastrointestinal disorders such as IBD, reflux and peptic ulcers
- Any adverse reaction to curcumin
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: SinaCurcumin®120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy | Drug | Curcumin plus RT |
| RTAlso: External Beam Radiation Therapy (EBRT)EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT | Radiation | Curcumin plus RT, Placebo plus RT |
| PlaceboAlso: SinaCurcumin® placeboPlacebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy | Drug | Placebo plus RT |
Primary outcome
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
Time frame: 90 days
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
4 secondary outcomes
Cystitis [assessed using CTCAE Grading Criteria]
Time frame: 90 days
Hematologic Toxicity
Time frame: 90 days
Biochemical progression-free survival (b-PFS)
Time frame: 5-years
Treatment Response
Time frame: 3 months after treatment termination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Abolfazl Razzaghdoust study director
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 Phase 2 study testing Curcumin and RT in people with Prostate Cancer, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)] (time frame: 90 days). 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 12 Oct 2017.