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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-3PUFAs group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-3PUFAs Treatment | Drug | Omega-3 plus (1200 mg) orally, twice a day for at least 12 months. |
|
| 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 |
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Inclusion Criteria:
- Patients who are at high risk for recurrence of NMIBC after TURBT based on the following tumor characteristics:
Exclusion Criteria:
- Patients with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Elkashef | Contact | +201000428981 | ahmed-elkashef@hotmail.com | |
| Mohamed Fadallah | Contact | +201061729388 | mohamedfadalah@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elkashef | Urology and Nephrology Center, Mansoura University, Egypt | Principal Investigator |
| Hassan Abol-Enein | Urology and Nephrology Center, Mansoura University, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center, Mansoura University | Recruiting | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Placebo Treatment | Drug | Placebo orally, twice a day for at least 12 months. |
|
|
| Ahmed A. Shokeir | Urology and Nephrology Center, Mansoura University, Egypt | Study Chair |
| D001749 |
| Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |