Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Grade II-III acute radiation-induced rectosigmoid injury

Signed informed consents

Age ≥18 years

Rstimated survival time >1 year

Disqualifiers

Absolute contraindications to glucocorticoids

A history of glucocorticoids treatment within 3 months

Inflammatory bowel disease or infectious intestinal disease

Recurrence of malignant tumor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.

  • Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation

    Drug

    Treatment according to guideline of radiation-induced intestinal injury.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Glucocorticoids+routine treatment groupExperimental treatment 2 interventions
Group B: Routine treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recovery and/or improvement

1. If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined. 2. If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined. The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy.

Time frame
3 months

Secondary outcomes

1

Recurrence and/or aggravation

Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.

Time frame
1 year
2

Adverse events

Any adverse event develop.

Time frame
1 year

Other outcomes

Sponsors and contacts

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