SCRUB study (SCRUB study)

Recruiting

• Conditions: Bladder Tumor; Bladder Cancer

• Registration Number: jRCTs051230084

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-09
• Study Start: 2023-09-01
• Last Update Posted: 2023-09-13

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: parallel assignment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative change in questionnaires regarding lower urinary tract symptoms		the IPSS and overactive bladder symptom score (OSBSS), excluding the primary outcome
Postoperative change in questionnaires regarding health-related quality of life		evaluation with SF-8, EORTC QLQ-C30, and FACT-BL
Postoperative change in questionnaires regarding sleep quality		evaluation with Pittsburgh Sleep Quality Index
Postoperative change in questionnaires regarding Nocturia-Quality of Life		evaluation with N-QOL
Postoperative change in questionnaires regarding urinary tract pain scale		evaluation with Numeric Pain Rating Scale (NPRS) etc.
Postoperative change of urinary frequency		evaluation with frequency volume chart, total urinary frequency per day, urinary frequency during daytime, urinary frequency during nighttime, total urinary volume per day, urinary volume during daytime, urinary volume during nighttime, average voided volume, average voided volume during daytime, average voided volume during nighttime
Rate of adverse events		evaluation with Common Terminology Criteria for Adverse Events ver 5.0
Urine concentration of hippuric acid		at Day 0 and Day 28