Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer
NCT ID: NCT04664816
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2020-12-01
2023-12-01
Brief Summary
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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 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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n-3PUFAs group
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.
n-3PUFAs Treatment
Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.
Control group
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.
Placebo Treatment
Placebo orally, twice a day for at least 12 months.
Interventions
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n-3PUFAs Treatment
Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.
Placebo Treatment
Placebo orally, twice a day for at least 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* ≥ T2 bladder cancer,
* Evidence of nodal metastasis,
* Associated upper tract urothelial carcinoma (UTUC) or
* Those who refuse.
18 Years
90 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ahmed Elkashef
Assistant Lecturer of Urology, Urology and Nephrology Center, Principal Investigator
Principal Investigators
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Ahmed Elkashef
Role: PRINCIPAL_INVESTIGATOR
Urology and Nephrology Center, Mansoura University, Egypt
Hassan Abol-Enein
Role: STUDY_DIRECTOR
Urology and Nephrology Center, Mansoura University, Egypt
Ahmed A. Shokeir
Role: STUDY_CHAIR
Urology and Nephrology Center, Mansoura University, Egypt
Locations
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Urology and Nephrology Center, Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed Elkashef
Role: primary
Other Identifiers
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Omega3-NMIBC
Identifier Type: -
Identifier Source: org_study_id