Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

NCT02724618 | Unknown Phase 2

• 1 other identifier: 406
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]

  Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)

  90 days

Secondary Outcomes (4)

• Cystitis [assessed using CTCAE Grading Criteria]

  90 days

• Hematologic Toxicity

  90 days

• Biochemical progression-free survival (b-PFS)

  5-years

• Treatment Response

  3 months after treatment termination

Study Arms (2)

Curcumin plus RT

EXPERIMENTAL

120mg/day nanocurcumin during RT course

Drug: Curcumin; Radiation: RT

Placebo plus RT

PLACEBO COMPARATOR

120mg/day placebo of nanocurcumin during RT course

Radiation: RT; Drug: Placebo

Interventions

Curcumin DRUG

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

Also known as: SinaCurcumin®

Curcumin plus RT

RT RADIATION

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

Also known as: External Beam Radiation Therapy (EBRT)

Curcumin plus RT; Placebo plus RT

Placebo DRUG

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

Also known as: SinaCurcumin® placebo

Placebo plus RT

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead
• Behnam Daheshpour Charity Organization, Tehran, Iran: collaborator

Study Sites (1)

Shohada-e-Tajrish Medical Center

Tehran, Iran

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Abolfazl Razzaghdoust

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 1, 2022
• Last Updated: October 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)