Effect of cranberry juice on treatment-induced lower Urinary symptoms in patients with bladder cancer:
A randomized control trial
(SCRUB study)
SCRUB study (SCRUB study)
Miyake Makito
Nara Medical University Hospital
840 Shijo-cho, Kashihara, Nara
+81-744-22-3051
makitomiyake@naramed-u.ac.jp
Miyake Makito
Nara Medical University Hospital
840 Shijo-cho, Kashihara, Nara
+81-744-22-3051
makitomiyake@naramed-u.ac.jp
Recruiting
Aug. 09, 2023
Sept. 01, 2023
110
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
other
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
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.
20age old over
80age old under
Both
Bladder Tumor; Bladder Cancer
Test group: 100% cranberry juice, 180 mL per day orally for 4 weeks (28 days)
Control group: Bottled water, 180 mL per day orally for 4 weeks (28 days)
Bladder; Benign Tumor; Urinary Neoplasm
100% cranberry juice or bottled water
D001749; D000093284 (ICD10 code: D414, C67)
The change of the IPSS scores at Day 28 after initiation of the intervention from the value prior to TURBT.
1) Postoperative change in questionnaires regarding lower urinary tract symptoms: the IPSS and overactive bladder symptom score (OSBSS), excluding the primary outcome
2) Postoperative change in questionnaires regarding health-related quality of life, evaluation with SF-8, EORTC QLQ-C30, and FACT-BL
3) Postoperative change in questionnaires regarding sleep quality: evaluation with Pittsburgh Sleep Quality Index
4) Postoperative change in questionnaires regarding Nocturia-Quality of Life: evaluation with N-QOL
5) Postoperative change in questionnaires regarding urinary tract pain scale: evaluation with Numeric Pain Rating Scale (NPRS) etc.
6) 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
7) Post-void residual volume
Safety outcomes (8 to 10)
8) Rate of adverse events (evaluation with Common Terminology Criteria for Adverse Events ver 5.0)
9) Change of blood tests
10) Change of urianalysis
Expiratory outcomes (11 to 13)
11) Supportive care with medicines such as pain reliever during the intervention
12) Urine concentration of hippuric acid at Day 0 and Day 28
13) Content of quinic acid and proanthocyanidin in 100% cranberry juice
