Efficacy of Diclofenac BCG Irrigations

Study Overview
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Brief Summary
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This study is designed to test the effectiveness of diclofenac suppositories in the prophylaxis of side effects caused by BCG bladder irrigations in bladder cancer patients.

Detailed Description
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This study is designed as a double blind placebo controlled randomized study to evaluate the effectiveness of diclofenac suppositories in the prevention of side effects of BCG bladder irrigation in bladder cancer patients. After signing an informed consent, the patients will be randomized to either receive an unmarked suppository of Diclofenac or a placebo suppository. The effectiveness of the drug will be tested weekly by quality of life questionnaires and bladder symptom questionnaire. Another questionnaire is designed to monitor the time in minutes that the BCG is retained in the bladder before the patients urinates.

Official Title
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Efficacy of Diclofenac Suppositories in Prevention of Immediate Side Effects of BCG Bladder Irrigations. A Double Blind Placebo Controlled Randomized Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: Abitren
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bladder urothelial carcinoma patients scheduled fo a set of 6 BCG bladder irrigations at the Carmel Medical Centre Male and female Age 20-80. Patients capable of understanding reading and signing the informed consent form in Hebrew. Exclusion Criteria: Diclofenac hypersensitivity Pregnancy, Lactation Elevated creatinine at baseline (male > 1.2 mg/% female 1.0 mg/%) Peptic gastric or duodenal ulcer Acute or chronic inflammation of the rectum/ anus (diarrhea, rectal bleeding) Gross hematuria (which is per se a contraindication for BCG irrigation)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diclofenac<br>suppositories to prevent BCG side effects | Drug: Abitren<br>* SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK<br>|
| Placebo Comparator: placebo suppositories<br> | Drug: Placebo<br>* Placebo suppositories<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weekly COOP Questionnaire 1 | The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week. | The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks | 
| Change in weekly COOP Questionnaire 2 | The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week. | The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks | 
| Change in weekly COOP Questionnaire 3 | The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the quality of life of the passing week. | The questionnaires will be completed every week for the quality of life of the passing week. The complete time frame of all questionnaires will be 7 weeks | 
| Change in weekly Bladder symptoms Questionnaire | Bladder symptoms Questionnaire correlated to BCG treatment. The bladder irrigations are delivered as an ambulatory treatment once a week. The questionnaires will be completed every week for the bladder symptoms of the passing week. | The questionnaires will be completed every week for the bladder symptoms of the passing week. The complete time frame of all questionnaires will be 7 weeks | 
| Change in weekly time schedule questionnaire | A questionnaire designed to measure the time in minutes that the patient was able to retain the BCG in the bladder.This questionnaire will be completed every week for the same day of weekly irrigation. | every week for 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diclofenac, BCG, BLADDER IRRIGATIONS