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

NCT04664816 | Unknown

• 1 other identifier: Omega3-NMIBC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

Non-muscle invasive bladder cancer;; Transurethral resection of bladder tumor;; Omega-3 polyunsaturated fatty acids.

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

n-3PUFAs group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

n-3PUFAs Treatment DRUG

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

Also known as: Treatment

n-3PUFAs group

Placebo Treatment DRUG

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

Also known as: Control

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- Patients with:
• ≥ T2 bladder cancer,
• Evidence of nodal metastasis,
• Associated upper tract urothelial carcinoma (UTUC) or
• Those who refuse.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ahmed Elkashef

  Urology and Nephrology Center, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

• Hassan Abol-Enein

  Urology and Nephrology Center, Mansoura University, Egypt

  STUDY DIRECTOR

• Ahmed A. Shokeir

  Urology and Nephrology Center, Mansoura University, Egypt

  STUDY CHAIR

Central Study Contacts

Ahmed Elkashef

CONTACT

+201000428981; ahmed-elkashef@hotmail.com

Mohamed Fadallah

CONTACT

+201061729388; mohamedfadalah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology, Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)