Overview

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

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mansoura University

Criteria

Inclusion Criteria:

- Patients who are at high risk for recurrence of NMIBC after TURBT based on the following
tumor characteristics:

- Stage Ta (G3, multifocal, or ≥ 2 occurrences within 12 months, including the current
tumor),

- Stage T1 (any grade) and/or,

- Carcinoma in situ (CIS),

- Without any indication for radical cystectomy.

Exclusion Criteria:

- Patients with:

- ≥ T2 bladder cancer,

- Evidence of nodal metastasis,

- Associated upper tract urothelial carcinoma (UTUC) or

- Those who refuse.