Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury

Официальное название

Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial

Обзор

Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines. Primary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate. Study Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients. Trial Duration: From February 2026 to February 2028. Intervention: Experimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion. Control Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion. Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.

Вмешательства

• Препарат Experimental Group (dexamethasone enema)
  Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.
• Препарат Control group (dexamethasone enema)
  Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.

Первичные конечные точки

• Improvement rate of radiation-induced rectal injury [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Severity of radiation-induced rectal injury [Срок оценки: 3 months]
• completion rate of pelvic radiotherapy [Срок оценки: 1 year]
• Incidence and severity of adverse events to dexamethasone enema [Срок оценки: 1 year]
• quality of life [Срок оценки: 1 year]
• pathological complete response (pCR) rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Aged 18 to 75 years, regardless of gender;
• Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;
• Patients pathologically diagnosed with rectal cancer;
• Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions);
• Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;
• Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.

Критерии исключения

• Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;
• Patients who have received pelvic radiotherapy;
• Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
• Pregnant or breastfeeding women;
• Patients expected to undergo major surgery during the study period;
• Participation in other clinical trials within 4 weeks prior to enrollment;
• A history of alcohol abuse, drug use, or substance abuse within the past year;
• Severe allergic constitution, or allergy to dexamethasone;
• Inability to cooperate with the enema;
• Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Публикации

• Mohammadianpanah M, Tazang M, Nguyen NP, Ahmadloo N, Omidvari S, Mosalaei A, Ansari M, Nasrollahi H, Kadkhodaei B, Khanjani N, Hosseini SV. Preventive efficacy of hydrocortisone enema for radiation proctitis in rectal cancer patients undergoing short-course radiotherapy: a phase II randomized placebo-controlled clinical trial. Ann Coloproctol. 2024 Oct;40(5):506-514. doi: 10.3393/ac.2024.00192.002 PMID 39434555
• Sanguineti G, Franzone P, Marcenaro M, Foppiano F, Vitale V. Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study. Strahlenther Onkol. 2003 Jul;179(7):464-70. doi: 10.1007/s00066-003-1082-4. PMID 12835883
• Kochhar R, Patel F, Dhar A, Sharma SC, Ayyagari S, Aggarwal R, Goenka MK, Gupta BD, Mehta SK. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci. 1991 Jan;36(1):103-7. doi: 10.1007/BF01300096. PMID 1670631
• 地塞米松在临床肿瘤治疗中的应用进展
• 放射性直肠损伤的预防与治疗临床实践指南
• 中国放射性直肠损伤多学科诊治专家共识（2021版）
• 中国放射性直肠炎诊治专家共识(2018版)
• Paquette IM, Vogel JD, Abbas MA, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of The American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis. Dis Colon Rectum. 2018 Oct;61(10):1135-1140. doi: 10.1097/DCR.0000000000001209. No abstract available. PMID 30192320

Идентификаторы

NCT: NCT07548736 · Dex-ARRI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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