Radiotherapy Section, Woman's Hospital - Caism/Unicamp, Campinas, SP, Brazil.
Department of Gynecology, Faculty of Medical Sciences, State University of Campinas - UNICAMP, Rua Alexander Fleming, 101, Cidade Universitária Zeferino Vaz, Campinas, SP, 13083-881, Brazil.
BMC Cancer. 2021 Jun 10;21(1):682. doi: 10.1186/s12885-021-08274-w.
We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer.
open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression.
the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37).
there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment.
Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.
我们旨在评估不同治疗选择对预防宫颈癌患者盆腔放疗后阴道狭窄发展的影响。
这是一项在巴西 UNICAMP 进行的 195 名 18-75 岁 I-IIIB 期女性的开放性随机临床试验，使用局部雌激素（66 例）、局部睾酮（34 例）、水基阴道润滑剂凝胶（66 例）和阴道扩张器（29 例）来评估放疗后阴道狭窄的发生率和严重程度，研究时间为 2013 年 1 月至 2018 年 5 月。主要观察指标为采用常见不良事件术语标准（CTCAE）量表评估的阴道狭窄程度和阴道容积的百分比变化。这些女性在四个不同时间点进行评估：放疗结束后不久，以及干预开始后 4、8 和 12 个月。采用对称性检验、Kruskal-Wallis 检验和多元回归进行统计学分析。
女性的平均年龄为 46.78（±13.01）岁，61.03%处于绝经前状态，73.84%为 IIB-IIIB 期肿瘤。总组的阴道容积平均减少 25.47%，四个治疗组的情况相似，整个干预期间无统计学差异。所有组在 1 年后 CTCAE 量表评估的阴道狭窄均加重（p<0.01），但使用阴道扩张器的组除外（p=0.37）。
所有分析的治疗组阴道容积均减少，组间无显著差异。然而，在接受一年治疗后，使用阴道扩张器的女性在 CTCAE 量表评估的阴道狭窄的频率和严重程度较低。
巴西临床试验注册处，RBR-23w5fv。于 2017 年 1 月 10 日注册 - 回顾性注册。
