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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    110
  • sponsor
    Mansoura University
Updated on 28 January 2021

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-Gurin (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.

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-Gurin (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.

Details
Condition Non Muscle Invasive Bladder Cancer
Treatment Placebo Treatment, n-3PUFAs Treatment
Clinical Study IdentifierNCT04664816
SponsorMansoura University
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Non Muscle Invasive Bladder Cancer??
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

Exclusion Criteria

Patients with
T2 bladder cancer
Evidence of nodal metastasis
Associated upper tract urothelial carcinoma (UTUC) or
Those who refuse
Clear my responses

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