- 2024-11
- International journal of radiation oncology, biology, physics 120(3)
- Jiawei Zhu
- Xiaofan Li
- Manni Huang
- Hong Zhu
- Yan Tan
- Xia He
- Zhihua Sun
- Huijun Cheng
- Fenghu Li
- Ping Jiang
- Hanmei Lou
- Guihao Ke
- Xinping Cao
- Lihong Zhu
- Peng Xie
- Junfang Yan
- Fuquan Zhang
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 142
- Population
- 283 patients with locally advanced cervical cancer
- Methods
- phase 3, randomized, open-label trial, experimental group treated with rhSOD enema during chemoradiation therapy, control group no enema
- Blinding
- Open-label
Purpose
The purpose of this study was to evaluate the efficacy of recombinant human superoxide dismutase (rhSOD) enemas in radiation-induced acute rectal injury (RARI) in patients with locally advanced cervical cancer.Methods and materials
In this phase 3, randomized, open-label trial (NCT04819685) conducted across 14 medical centers in China from June 2021 to August 2023, all patients received concurrent chemoradiation therapy (CCRT). The experimental group was treated with a rhSOD enema during chemoradiation therapy, and the control group had no enema. The Common Terminology Criteria for Adverse Events (version 5.0) was used to evaluate radiation therapy-induced side effects. Endoscopic appearance was assessed using the Vienna Rectoscopy Score. The primary endpoint in the acute phase was the occurrence rate and duration of grade ≥1 (≥G1) diarrhea during CCRT. Secondary endpoints included the occurrence rate and duration of ≥G2 and ≥G3 diarrhea, ≥G1 and ≥G2 diarrhea lasting at least 3 days, and damage to the rectal mucosa due to radiation therapy measured by endoscopy.Results
Two hundred and eighty-three patients were randomly divided into the experimental (n = 141) or control group (n = 142). The mean number of ≥G1 and ≥G2 diarrhea days were significantly lower in the experimental group than in the control group (3.5 and 0.8 days vs 14.8 and 4.5 days, respectively; P < .001). The incidence of ≥G2 diarrhea decreased from 53.6% to 24.1% when rhSOD enemas were used. Use of antidiarrheals was lower in the experimental group (36.2% vs 55.7%, P < .001). Three patients felt intolerable or abdominal pain after rhSOD enema. RARI grades in the experimental group tended to be lower than those in the control group (P = .061). Logistic regression analysis revealed that rhSOD enema was associated with a lower occurrence rate of ≥G1/2 diarrhea for at least 3 days (P < .001).Conclusions
The results of this study suggest that rhSOD enema is safe and significantly reduces the incidence, severity, and duration of RARI, protecting the rectal mucosa.