一款用于优化前列腺癌患者放疗期间膀胱充盈的提醒应用程序（REFILL-PAC）：一项前瞻性试验的方案
A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial.
作者信息
Rades Dirk, Küter Jan-Dirk, von Staden Michael, Al-Salool Ahmed, Janssen Stefan, Timke Carmen, Duma Marciana Nona, Bartscht Tobias, Vestergård Madsen Christine, Kristiansen Charlotte, Cremers Florian
机构信息
Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Campus Lübeck, Lubeck, Germany.
Department of Radiation Oncology, University of Lübeck, Lubeck, Germany.
出版信息
JMIR Res Protoc. 2025 Apr 8;14:e68179. doi: 10.2196/68179.
BACKGROUND
Many patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone.
OBJECTIVE
The primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course.
METHODS
This ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles.
RESULTS
Recruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026.
CONCLUSIONS
This trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer.
TRIAL REGISTRATION
Clinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/68179.
背景
许多非转移性前列腺癌患者接受放射治疗，这可能与急性膀胱炎有关，尤其是当膀胱体积较小时。三项研究表明，膀胱体积<200 ml或<180 ml与泌尿毒性增加有关。因此，在尽可能多的放疗分次期间保持膀胱体积大于200 ml很重要。几项研究调查了饮水方案，即要求患者在放疗前饮用一定量的水。这可能需要患者具备相当的自律性，而这些患者主要是老年人。一款提醒患者在每次放疗前饮水的移动应用程序可能有助于患者遵守饮水方案。本研究调查了此类应用程序对仅接受体外放射治疗（EBRT）的前列腺癌患者膀胱充盈状态的影响。
目的
本研究的主要目标是评估一款提醒前列腺癌放疗患者在每次放疗前饮用300 ml水的应用程序对放疗过程中膀胱体积<200 ml的分次次数的影响。
方法
这项正在进行的2期研究旨在招募28例仅接受EBRT治疗的非转移性前列腺癌患者。放疗将采用常规分割，剂量范围为70至80 Gy，分35至40次，每次2 Gy，最好采用容积调强弧形放疗（VMAT）。治疗体积包括前列腺，可包括或不包括精囊。
结果
该试验将于2025年3月开始招募，计划于2026年10月完成。该研究计划于2026年12月结束。
结论
本试验首次评估了提醒应用程序对局部前列腺癌放疗患者膀胱体积<200 ml的放疗分次次数的影响。
试验注册
Clinicaltrials.gov NCT06653751；https://clinicaltrials.gov/show/NCT06653751。
国际注册报告识别码（IRRID）：PRR1-10.2196/68179。
Zotero 插件