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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The thalidomide group | Experimental | Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks. |
|
| The glutamine group | Experimental | Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. |
|
| The thalidomide combined with glutamine group | Experimental | Patients in the thalidomide combined with glutamine group will receive oral thalidomide at a dosage of 100 mg one time daily and two enteric-soluble capsules of compound glutamine three times a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response rate. | The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment. | From enrollment to the end of treatment at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| No further bleeding occurred within 1 week after treatment | Stool occult blood negative 2 times in a row on different dates | From enrollment to the end of treatment at 8 weeks. |
| Number of blood transfusions during the treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi | Contact | 0086 + 02984771515 | shiyquan@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, National Clinical Research Center for Digestive Diseases, Department of Gastroenterology & Hepatology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Ch | Recruiting | Xi'an | Shaanxi |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Glutamine | Drug | In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks. |
|
|
| Thalidomide+Glutamine | Drug | 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. |
|
times
| From enrollment to the end of treatment at 8 weeks. |
| Red blood cell input | Input red blood cells according to the situation | From enrollment to the end of treatment at 8 weeks. |
| Hemoglobin level | Record each test result | From enrollment to the end of treatment at 8 weeks. |
| Number of hospitalizations due to bleeding | times | From enrollment to the end of treatment at 8 weeks. |
| Number of days in hospital due to bleeding | days | From enrollment to the end of treatment at 8 weeks. |
| Require surgery | yes or no | From enrollment to the end of treatment at 8 weeks. |
| 710005 |
| China |
|
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D021542 | Amino Acids, Neutral |