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

Mansoura University

Status: Unknown

Conditions: Non-Muscle Invasive Bladder Cancer

Treatments: Drug: n-3PUFAs Treatment; Drug: Placebo Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04664816

Omega3-NMIBC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

n-3PUFAs group

Experimental group

Description:

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.

Treatment:

Drug: n-3PUFAs Treatment

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Treatment