SCRUB study

Phase 2

Recruiting

• Conditions: Bladder; Bladder Tumor; Bladder Cancer; Benign Tumor; Urinary Neoplasm; D001749; D000093284 (ICD10 code: D414, C67)

• Registration Number: JPRN-jRCTs051230084
• Lead Sponsor: Miyake Makito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1) Patients with bladder tumor who underwent the transurethral resection of bladder tumor within 10 days prior to the study registration
2) ECOG-performance status is 0 or 1
3) Age, between 20 and 80 years-old
4) The name and condition of the disease have been announced to the patient, and he / she must be given an explanation when participating in this study. The written consent at his / her will must be obtained with sufficient understanding.
5) Bone marrow function and organ functions are sufficient within 60 days prior to the study registration. For a case in whom multiple examination data are available, use most recent data before surgery.
- Hemoglobin: 9.0 g/dL or more
- White blood cell count: the lower limit to 12,000/mm3
- Neutrophil count: 1,500/mm3 or more
- Platelet count: 75,000/mm3 or more
- Total bilirubin: 2-fold of the upper limit of normal or less
- Aspartate aminotransferase (AST): 2-fold of the upper limit of normal or less and Alanine aminotransferase (ALT): 2-fold of the upper limit of normal or less
- Serum creatinine: 2-fold of the upper limit of normal or less

Exclusion Criteria

1) Patients with a habit of drinking alcohol, more than 20 gram per day.
2) Patients with uncontrolled diabetes, defined as HbA1c level > 8.0%.
3) Patients with a history of allergic reaction to any cranberry products.
4) Patients with a habit of taking any cranberry products three times per week of more.
5) Patients who prefers to taking any cranberry products perioperatively.
6) Patients with post-void residual volume > 100 mL or those who need to perform clean intermittent catherterization.
7) Patients with active urinary tract infection before the transurethral resection of bladder tumor.
8) Patients with severe lower urinary symptom, defined as International Prostate Symptom Score total score of 20 to 35.
9) Patients with severe symptomatic heart failure, defined as New York Heart Association (NYHA) Functional Classification III or IV.
10) Pregnant women, lactating women and patients who may be pregnant.
11) Patients who cannot understand the trial or take the medicine on his/her own initiative.
12) Inappropriate for the enrolment by the judgement of the principal investigator or the subinvestigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of the IPSS scores at Day 28 after initiation of the intervention from the value prior to TURBT.