BackgroundThe present prospective study evaluated the safety and efficacy of the rectum following KUSHEN Ningjiaos in cervical cancer. We compared rectal wall changes during brachytherapy with or without KUSHEN Ningjiaos in cervical cancer patients and analyzed the difference in spatial dose distribution, including whole rectum-wall (R-w), anterior rectum-wall (R-a) and posterior rectum-wall (R-p).Methods and materialsOne hundred cervical cancer patients with and without KUSHEN Ningjiaos were treated with brachytherapy (600 cGy). The whole R-w was divided into two areas of R-a and R-p, and R-w dose surface map were constructed. The volume of each R-w was compared in patients pre- and post-KUSHEN Ningjiaos.ResultsWhen the pre- vs. post-KUSHEN groups were compared the volume of R-w increased. In the post-KUSHEN group, a significantly higher proportion of the D2cc of VR-w and VR-a compared with the pre-KUSHEN group showed that the D2ccmean increased from 532.45 cGy to 564.7 cGy and 533.51 cGy to 565.26 cGy, respectively; however, results demonstrated a decrease in the D2ccmean of R-p from 260.5 cGy to 240.0868 cGy (P < 0.05). The insertion of KUSHEN Ningjiaos resulted in a reduction of the relative volume of R-p exposed to high doses, and regressive analysis showed that the DR-p-max correlated most strongly with VR-w and D2ccR-p (P < 0.01 and P < 0.05, respectively).ConclusionThe insertion of KUSHEN Ningjiaos can protect the rectum. KUSHEN Ningjiaos appears to be safe and well tolerated; therefore, we believe that there will be fewer adverse events after brachytherapy for patients.Trial registrationA multi-center, prospective clinical trial for KUSHEN Ningjiaos was inserted into rectum to reduce the rate of radiation proctitis in three-dimensional brachytherapy of cervical cancer. ChiCTR1900021631. 2 Mar 2019-Retrospectively registered.