Non-Muscle Invasive Bladder CancerNCT04664816
Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer
A study testing n-3PUFAs Treatment in people with Non-Muscle Invasive Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- n-3PUFAs Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with:
- ≥ T2 bladder cancer,
- Evidence of nodal metastasis,
- Associated upper tract urothelial carcinoma (UTUC) or
- Those who refuse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center, Mansoura University
Al Mansurah
Ahmed Elkashef, +201000428981, ahmed-elkashef@hotmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- n-3PUFAs Treatment, Placebo Treatment
- Keywords
- Non-muscle invasive bladder cancer;, Transurethral resection of bladder tumor;, Omega-3 polyunsaturated fatty acids.
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3PUFAs TreatmentDrug
Also called Treatment
Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.
Placebo TreatmentDrug
Also called Control
Placebo orally, twice a day for at least 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elkashef, Mansoura University
- Investigators
- Ahmed Elkashef, Principal investigator, Urology and Nephrology Center, Mansoura University, EgyptHassan Abol-Enein, Study director, Urology and Nephrology Center, Mansoura University, EgyptAhmed A. Shokeir, Study chair, Urology and Nephrology Center, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664816
- Sponsor's protocol ID
- Omega3-NMIBC
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04664816
- Acronym / sponsor ID
- Omega3-NMIBC
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Keywords
- Non-muscle invasive bladder cancer;, Transurethral resection of bladder tumor;, Omega-3 polyunsaturated fatty acids.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3PUFAs group | Experimental | Drug: n-3PUFAs TreatmentThese 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. |
| Control group | Placebo comparator | Drug: Placebo TreatmentThese 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients with:
- ≥ T2 bladder cancer,
- Evidence of nodal metastasis,
- Associated upper tract urothelial carcinoma (UTUC) or
- Those who refuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3PUFAs TreatmentAlso: TreatmentOmega-3 plus (1200 mg) orally, twice a day for at least 12 months. | Drug | n-3PUFAs group |
| Placebo TreatmentAlso: ControlPlacebo orally, twice a day for at least 12 months. | Drug | Control group |
Primary outcome
Time to first recurrence.
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elkashef principal investigator
Urology and Nephrology Center, Mansoura University, Egypt
Hassan Abol-Enein study director
Urology and Nephrology Center, Mansoura University, Egypt
Ahmed A. Shokeir study chair
Urology and Nephrology Center, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3PUFAs Treatment in people with Non-Muscle Invasive Bladder Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elkashef (+201000428981, ahmed-elkashef@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.