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NCT Number: NCT07548736

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location contact

Xiaosheng He

CONTACT

[email protected]

+862085655905

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Experimental Group (dexamethasone enema)

Drug

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 (dexamethasone enema)

Drug

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.

Primary outcomes

  1. Improvement rate of radiation-induced rectal injury

    Time frame: 3 months

Secondary outcomes

  1. Severity of radiation-induced rectal injury

    Time frame: 3 months

    Assessment criteria: Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring system, Vienna Rectoscopy Score

  2. completion rate of pelvic radiotherapy

    Time frame: 1 year

  3. Incidence and severity of adverse events to dexamethasone enema

    Time frame: 1 year

    assessed according to CTCAE v.5

  4. quality of life

    Time frame: 1 year

    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  5. pathological complete response (pCR) rate

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaosheng He

CONTACT

[email protected]

+862085655905

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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