An interventional study of n-3PUFAs Treatment and Placebo Treatment in Non-Muscle Invasive Bladder Cancer, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
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.
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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
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
Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.
Also known as: Treatment
Placebo orally, twice a day for at least 12 months.
Also known as: Control
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.
Time frame: 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.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Mansoura University