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

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04664816

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Muscle Invasive Bladder Cancer	Drug: n-3PUFAs Treatment Drug: Placebo Treatment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: n-3PUFAs group 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.	Drug: n-3PUFAs Treatment Omega-3 plus (1200 mg) orally, twice a day for at least 12 months. Other Names: Treatment
Placebo Comparator: Control group 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.	Drug: Placebo Treatment Placebo orally, twice a day for at least 12 months. Other Names: Control

Arm

Intervention/Treatment

Experimental: n-3PUFAs group

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.

Drug: n-3PUFAs Treatment

Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.

Other Names:

Treatment

Placebo Comparator: Control group

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.

Drug: Placebo Treatment

Placebo orally, twice a day for at least 12 months.

Other Names:

Control

Outcome Measures

Primary Outcome Measures

Time to first recurrence. [2 years]
Time to first recurrence is defined as the length of time from surgery to the first bladder recurrence or until last follow up.
Recurrence-free survival [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center, Mansoura University	Mansoura		Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Ahmed Elkashef, Urology and Nephrology Center, Mansoura University, Egypt
Study Director: Hassan Abol-Enein, Urology and Nephrology Center, Mansoura University, Egypt
Study Chair: Ahmed A. Shokeir, Urology and Nephrology Center, Mansoura University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Elkashef, Assistant Lecturer of Urology, Urology and Nephrology Center, Principal Investigator, Mansoura University

ClinicalTrials.gov Identifier:

NCT04664816

Other Study ID Numbers:

Omega3-NMIBC

First Posted:

Dec 11, 2020

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Elkashef, Assistant Lecturer of Urology, Urology and Nephrology Center, Principal Investigator, Mansoura University

Non-muscle invasive bladder cancer;

Transurethral resection of bladder tumor;

Omega-3 polyunsaturated fatty acids.

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Dec 21, 2020