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Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer

NCT04664816 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-12-21

No results posted yet for this study

Summary

The investigators hypothesize that omega-3 polyunsaturated fatty acids (n-3 PUFAs) might have a role in prevention of the recurrence of non-muscle invasive bladder cancer (NMIBC).

The patients who are suffering from high-risk NMIBC will be randomly allocated into two groups: The first group (n-3 PUFAs group): 55 patients will receive omega-3 plus twice daily for one year after transurethral resection of bladder tumor (TURBT). The second group (Control group): 55 patients will receive placebo twice daily for one year after TURBT.

All patients will receive intravesical Bacillus Calmette-Guérin (BCG) immunotherapy and they will be followed up for two years.

The chemopreventive effect of n-3 PUFAs on the recurrence of NMIBC after TURBT will be studied via magnetic resonance imaging (MRI), inpatient cystoscopy, histopathological examination and molecular studies of the resected bladder tissues.

Conditions

Interventions

DRUG

n-3PUFAs Treatment

Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.

DRUG

Placebo Treatment

Placebo orally, twice a day for at least 12 months.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed Elkashef · Urology and Nephrology Center, Mansoura University, Egypt

  • Hassan Abol-Enein · Urology and Nephrology Center, Mansoura University, Egypt

  • Ahmed A. Shokeir · Urology and Nephrology Center, Mansoura University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664816 on ClinicalTrials.gov