Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
NCT ID: NCT04680195
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
62 participants
INTERVENTIONAL
2020-12-14
2022-12-30
Brief Summary
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Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. For the patients of CRP with intractable bleeding, a prospective, open clinical trial will be carried out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
Detailed Description
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Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. A large number of studies have shown that thalidomide can be used to treat Crohn's disease, ulcerative colitis, radiation cystitis, etc., and it can treat moderate to severe of IBD patients can inhibit inflammatory response, improve clinical symptoms, promote intestinal mucosal repair. Further, recent studies have proved that thalidomide can be used to treat intestinal bleeding due to vascular dysplasia. And a case report from Gut described that refractory bleeding of CRP of a 78-year-old woman were significantly alleviated after taking thalidomide.
Therefore, for the patients of CRP with intractable bleeding, a prospective, open clinical trial planed to carry out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thalidomide treatment Group
Induction period:
Thalidomide tablets: 50-100 mg/d, qn, po.
Maintenance period:
Thalidomide tablets: 50-75 mg/d qn, po.
Thalidomide
The patients were treated with thalidomide tanken orally every night for 4 months, and the treatment period was divided into induction period and maintenance period, as follows:
Induction period:
The oral dose of thalidomide started at 50 mg, and increased to 100 mg after one week if tolerable, and maintain 100 mg for three weeks. The medication time was 1 month.
Maintenance period: The oral dose of thalidomide was 50-75mg/d. The medication time was 3 months.
Interventions
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Thalidomide
The patients were treated with thalidomide tanken orally every night for 4 months, and the treatment period was divided into induction period and maintenance period, as follows:
Induction period:
The oral dose of thalidomide started at 50 mg, and increased to 100 mg after one week if tolerable, and maintain 100 mg for three weeks. The medication time was 1 month.
Maintenance period: The oral dose of thalidomide was 50-75mg/d. The medication time was 3 months.
Eligibility Criteria
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Inclusion Criteria
2. Patients with ECOG physical condition score of 0-2;
3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
5. Patients with no primary tumor recurrence or metastasis;
6. Patients with refractory hemorrhagic CRP who have failed to conventional treatment (SOMA score for hematochezia≥2, hemoglobin level ≤90g/L, or a history of blood transfusion due to CRP)
7. Subjects and their family members can understand the research plan, and are willing to participate, and sign an informed consent form.
Exclusion Criteria
2. Patients with severe complications of CRP, such as Rectal ulcer (VRS\>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
3. Patients with a history of rectal resection;
4. Other bleeding diseases, such as grade III or IV hemorrhoids, coagulation dysfunction, etc.;
5. Patients with other diseases requiring long-term use of anticoagulant drugs;
6. Combined intestinal obstruction, requiring surgery;
7. The absolute value of neutrophils of patients is lower than 750/mm3;
8. Patients who are allergic to thalidomide;
9. Pregnant or lactating women;
10. Patients with severe mental illness;
11. Patients who cannot take medication or follow up as planned;
12. During the trial and within 3 months after the trial, the subjects and their partners are not willing to contraception;
13. Participants in other clinical investigators 3 months before the trial
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Central Contacts
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References
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Yuan ZX, Ma TH, Zhong QH, Wang HM, Yu XH, Qin QY, Chu LL, Wang L, Wang JP. Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and Risk Factors for Fistula Development. Asian Pac J Cancer Prev. 2016;17(2):631-8. doi: 10.7314/apjcp.2016.17.2.631.
Andreyev HJ. Argon plasma coagulation in chronic radiation proctitis: Postgate et al. Endoscopy. 2007 Aug;39(8):751-2; author reply 752. doi: 10.1055/s-2007-966772. No abstract available.
Craanen ME, van Triest B, Verheijen RH, Mulder CJ. Thalidomide in refractory haemorrhagic radiation induced proctitis. Gut. 2006 Sep;55(9):1371-2. doi: 10.1136/gut.2006.099416. No abstract available.
Zhou S, Wang F, Hsieh TC, Wu JM, Wu E. Thalidomide-a notorious sedative to a wonder anticancer drug. Curr Med Chem. 2013;20(33):4102-8. doi: 10.2174/09298673113209990198.
Yuan ZX, Ma TH, Wang HM, Zhong QH, Yu XH, Qin QY, Wang JP, Wang L. Colostomy is a simple and effective procedure for severe chronic radiation proctitis. World J Gastroenterol. 2016 Jun 28;22(24):5598-608. doi: 10.3748/wjg.v22.i24.5598.
Kim KT, Chae HS, Kim JS, Kim HK, Cho YS, Choi W, Choi KY, Rho SY, Kang SJ. Thalidomide effect in endothelial cell of acute radiation proctitis. World J Gastroenterol. 2008 Aug 14;14(30):4779-83. doi: 10.3748/wjg.14.4779.
Bauditz J, Wedel S, Lochs H. Thalidomide reduces tumour necrosis factor alpha and interleukin 12 production in patients with chronic active Crohn's disease. Gut. 2002 Feb;50(2):196-200. doi: 10.1136/gut.50.2.196.
Alberto SF, Felix J, de Deus J. Thalidomide for the treatment of severe intestinal bleeding. Endoscopy. 2008 Sep;40(9):788; author reply 789. doi: 10.1055/s-2008-1077513. Epub 2008 Sep 4. No abstract available.
Bauditz J, Schachschal G, Wedel S, Lochs H. Thalidomide for treatment of severe intestinal bleeding. Gut. 2004 Apr;53(4):609-12. doi: 10.1136/gut.2003.029710.
McCrone LF, Neary PM, Larkin J, McCormick P, Mehigan B. The surgical management of radiation proctopathy. Int J Colorectal Dis. 2017 Aug;32(8):1099-1108. doi: 10.1007/s00384-017-2803-y. Epub 2017 Apr 20.
Ma TH, Yuan ZX, Zhong QH, Wang HM, Qin QY, Chen XX, Wang JP, Wang L. Formalin irrigation for hemorrhagic chronic radiation proctitis. World J Gastroenterol. 2015 Mar 28;21(12):3593-8. doi: 10.3748/wjg.v21.i12.3593.
Other Identifiers
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HOPE2020-Thal-CRP
Identifier Type: -
Identifier Source: org_study_id