Annals of Coloproctology

  • 제40권5호
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  • Pages.506-514
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  • 2024
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  • 2287-9714(pISSN)
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  • 2287-9722(eISSN)
대한대장항문학회 (The Korean Society of Coloproctology)
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Preventive efficacy of hydrocortisone enema for radiation proctitis in rectal cancer patients undergoing short-course radiotherapy: a phase II randomized placebo-controlled clinical trial

  • Mohammad Mohammadianpanah (Colorectal Research Center, Shiraz University of Medical Sciences) ;
  • Maryam Tazang (Student Research Committee, School of Medicine, Shiraz University of Medical Sciences) ;
  • Nam Phong Nguyen (Department of Radiation Oncology, Howard University) ;
  • Niloofar Ahmadloo (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Shapour Omidvari (Breast Diseases Research Center, School of Medicine, Shiraz University of Medical Sciences) ;
  • Ahmad Mosalaei (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Mansour Ansari (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Hamid Nasrollahi (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Behnam Kadkhodaei (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Nezhat Khanjani (Department of Radiation Oncology, School of Medicine, Shiraz University of Medical Sciences) ;
  • Seyed Vahid Hosseini (Colorectal Research Center, Shiraz University of Medical Sciences)
  • 투고 : 2024.03.14
  • 심사 : 2024.06.19
  • 발행 : 2024.10.31
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초록

Purpose: This study aimed to investigate the efficacy of hydrocortisone enema in preventing radiation proctitis in patients with rectal cancer undergoing short-course radiotherapy (SCRT). Methods: This phase II randomized controlled trial enrolled patients with newly diagnosed locally advanced rectal cancer (clinically staged T3-4 and/or N1-2M0). Participants received a median of 4 cycles of neoadjuvant chemotherapy (capecitabine plus oxaliplatin) followed by 3-dimensional conformal SCRT (25 Gy in 5 fractions). Patients were randomly assigned to receive either a hydrocortisone enema (n = 50) or a placebo (n = 51) once daily for 5 consecutive days during SCRT. The primary endpoint was the incidence and severity of acute proctitis. Results: Of the 111 eligible patients, 101 were included in the study. Baseline characteristics, including sex, age, performance status, and tumor location, were comparable across the treatment arms. None of the patients experienced grade 4 acute gastrointestinal toxicity or had to discontinue treatment due to treatment-related adverse effects. Patients in the hydrocortisone arm experienced significantly less severe proctitis (P < 0.001), diarrhea (P = 0.023), and rectal pain (P < 0.001) than those in the placebo arm. Additionally, the duration of acute gastrointestinal toxicity following SCRT was significantly shorter in patients receiving hydrocortisone (P < 0.001). Conclusion: Hydrocortisone enema was associated with a significant reduction in the severity of proctitis, diarrhea, and rectal pain compared to placebo. Additionally, patients treated with hydrocortisone experienced shorter durations of gastrointestinal toxicity following SCRT. This study highlights the potential benefits of hydrocortisone enema in managing radiation-induced toxicity in rectal cancer patients undergoing radiotherapy.

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과제정보

The clinical trial was supported by Shiraz University of Medical Sciences (Shiraz, Iran).

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