Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

Официальное название

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study

Обзор

At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.

Подробное описание

Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.

Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.

Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.

Вмешательства

• Препарат Thalidomide
  Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
• Препарат Glutamine
  In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.
• Препарат Thalidomide+Glutamine
  Patients in thalidomide combined with glutamine group took thalidomide orally at a dose of 100mg once a day and two capsules of glutamine were taken orally 3 times a day for 8 weeks.

Первичные конечные точки

• Treatment response rate. [Срок оценки: From enrollment to the end of treatment at 8 weeks.]

Вторичные конечные точки (7)

• No further bleeding occurred within 1 week after treatment [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Number of blood transfusions during the treatment period [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Red blood cell input [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Hemoglobin level [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Number of hospitalizations due to bleeding [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Number of days in hospital due to bleeding [Срок оценки: From enrollment to the end of treatment at 8 weeks.]
• Require surgery [Срок оценки: From enrollment to the end of treatment at 8 weeks.]

Критерии участия

Критерии включения

• Age 18-80 years old, gender is not limited;
• Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
• The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
• ECOG score: 0-2.

Критерии исключения

• Patients with hemodynamic instability;
• Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
• Patients allergic to thalidomide or glutamine;
• Patients whose primary disease was gastrointestinal malignancy;
• Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
• Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
• Patients infected with HIV;
• Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
• any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Natio — Сиань

Идентификаторы

NCT: NCT06617182 · KY20242229-F-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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