Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664816
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-01
Brief Title:
Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None