Non-Muscle Invasive Bladder Cancer Clinical Trial
Official title:
Chemopreventive Effect of Omega-3 Polyunsaturated Fatty Acids on the Recurrence of Non-Muscle Invasive Bladder Cancer: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center, Mansoura University | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first recurrence. | Time to first recurrence is defined as the length of time from surgery to the first bladder recurrence or until last follow up. | 2 years | |
Primary | Recurrence-free survival | Recurrence-free survival is defined as the length of time after treatment of non-muscle invasive bladder cancer that the patient survives without any radiological, histopathological, immunohistochemical or molecular evidence of tumor recurrence. | 2 years |
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