Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724618

Enrollment

Registered

2016-03-31

Start date

2016-03-31

Completion date

2022-04-30

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Curcumin, Protection, Radiation, Controlled Clinical Trials, Randomized, Radiation Therapy, Prostate Cancer

Brief 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.

Interventions

DRUGCurcumin

120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy

RADIATIONRT

EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT

DRUGPlacebo

Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Histologically confirmed adenocarcinoma of the prostate * Candidate for External Beam Radiotherapy * ECOG performance status 0-2

Exclusion criteria

* Patients with Metastatic Prostate Cancer * Patients with Kidney & Liver dysfunction * Gastrointestinal disorders such as IBD, reflux and peptic ulcers * Any adverse reaction to curcumin

Design outcomes

Primary

Measure	Time frame	Description
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]	90 days	Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)

Secondary

Measure	Time frame	Description
Cystitis [assessed using CTCAE Grading Criteria]	90 days	Cystitis as assessed using CTCAE Grading Criteria
Hematologic Toxicity	90 days	Hematologic Toxicity as assessed by significant reduction in hematologic components
Biochemical progression-free survival (b-PFS)	5-years	b-PFS as assessed using Prostate-Specific Antigen (PSA)
Treatment Response	3 months after treatment termination	Treatment Response as assessed using Magnetic Resonance Imaging techniques

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026