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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (1200 mg) orally, twice a day for at least 12 months. The treatment will start after transurethral resection of bladder tumor (TURBT), as soon as the histopathology will be obtained. The treatment will be discontinued if recurrence develops, unacceptable or serious adverse events occur or according to the patients' request. The second group (Control group): 55 patients will receive placebo twice daily for one year after TURBT. Patients and care providers will be blinded to the medication given. 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.

Official Title
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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

Conditions
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Non-Muscle Invasive Bladder Cancer

Intervention / Treatment
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* Drug: n-3PUFAs Treatment
* Drug: Placebo Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3PUFAs group<br>These patients will receive omega-3 plus (1200 mg) orally, twice a day for at least 12 months. The treatment will start after TURBT, as soon as the histopathology will be obtained. The treatment will be discontinued if recurrence develops, unacceptable or serious adverse events occur or according to the patients' request. | Drug: n-3PUFAs Treatment<br>* Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.<br>* Other names: Treatment;|
| Placebo Comparator: Control group<br>These patients will receive placebo orally, twice a day for at least 12 months. The treatment will start after TURBT, as soon as the histopathology will be obtained. The treatment will be discontinued if recurrence develops, unacceptable or serious adverse events occur or according to the patients' request. | Drug: Placebo Treatment<br>* Placebo orally, twice a day for at least 12 months.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-muscle invasive bladder cancer;, Transurethral resection of bladder tumor;, Omega-3 polyunsaturated fatty acids.