Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Curcumin; Drug: Placebo; Radiation: RT

Study type: Interventional

Funder types: Other

Identifiers

NCT02724618

406

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Curcumin plus RT

Experimental group

Description:

120mg/day nanocurcumin during RT course

Treatment:

Radiation: RT

Drug: Curcumin

Placebo plus RT

Placebo Comparator group

Description:

120mg/day placebo of nanocurcumin during RT course

Treatment:

Radiation: RT

Drug: Placebo