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

Not Applicable

• Conditions: Non-Muscle Invasive Bladder Cancer
• Interventions: Drug: Placebo Treatment; Drug: n-3PUFAs Treatment

• Registration Number: NCT04664816
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-01
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

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Exclusion Criteria

• Patients with:

• ≥ T2 bladder cancer,
• Evidence of nodal metastasis,
• Associated upper tract urothelial carcinoma (UTUC) or
• Those who refuse.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo Treatment	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.
n-3PUFAs group	n-3PUFAs Treatment	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.

Primary Outcome Measures

Name	Time	Method
Time to first recurrence.	2 years	Time to first recurrence is defined as the length of time from surgery to the first bladder recurrence or until last follow up.
Recurrence-free survival	2 years	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.

Trial Locations

Locations (1)

Urology and Nephrology Center, Mansoura University; 🇪🇬 Mansoura, Egypt