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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: n-3PUFAs Treatment; Drug: Placebo Treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Fadallah; Phone Number: +201061729388; Email: mohamedfadalah@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Urology and Nephrology center, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Hassan Abol-Enein, Urology and Nephrology Center, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Non-muscle invasive bladder cancer;; Transurethral resection of bladder tumor;; Omega-3 polyunsaturated fatty acids.
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: Omega3-NMIBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No