Clinical trial NCT04664816: Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Muscle Invasive Bladder Cancer
Keywords: Non-muscle invasive bladder cancer;
Transurethral resection of bladder tumor;
Omega-3 polyunsaturated fatty acids.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

- 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.

Primary outcomes:
measure: Time to first recurrence.
timeFrame: 2 years
measure: Recurrence-free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center, Mansoura University
Study officials:
affiliation: Urology and Nephrology Center, Mansoura University, Egypt
name: Ahmed Elkashef
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology and Nephrology Center, Mansoura University, Egypt
name: Hassan Abol-Enein
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology Center, Mansoura University, Egypt
name: Ahmed A. Shokeir
role: STUDY_CHAIR
References: