Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding

NCT04680195 | Unknown Phase 2

• 1 other identifier: HOPE2020-Thal-CRP
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic radiation proctitis (CRP) is the main secondary toxic injury after pelvic radiotherapy. Hematochezia is the most common symptom for more than 80% of CRP patients. 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.

Conditions

Chronic Radiation Proctitis

Keywords

Thalidomide; Bleeding; Chronic radiation proctitis

Outcome Measures

Primary Outcomes (1)

• Remission rate of rectal bleeding one month after thalidomide treatment

  Remission of rectal bleeding was defined as the score of Subjective Objective Management Analysis system (SOMA) for retcal bleeding at least 1 grade lower and the hemoglobin level at least 10g/L higher than that before treatment. The SOMA score for hematochezia was ranged from 1 to 4, with the higher the score, the more serious.

  the first month after thalidomide treatment

Secondary Outcomes (20)

• Remission rate of rectal bleeding one month during thalidomide treatment

  the first month during thalidomide treatment

• Remission rate of rectal bleeding two months during thalidomide treatment

  the second month during thalidomide treatment

• Remission rate of rectal bleeding three months during thalidomide treatment

  the third month during thalidomide treatment

• Remission rate of rectal bleeding four months during thalidomide treatment

  the fourth month during thalidomide treatment

• Remission rate of rectal bleeding three months after thalidomide treatment

  the third month after thalidomide treatment

Study Arms (1)

Thalidomide treatment Group

EXPERIMENTAL

Induction period: Thalidomide tablets: 50-100 mg/d, qn, po. Maintenance period: Thalidomide tablets: 50-75 mg/d qn, po.

Drug: Thalidomide

Interventions

Thalidomide DRUG

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.

Thalidomide treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years;
• Patients with ECOG physical condition score of 0-2;
• Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
• Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
• Patients with no primary tumor recurrence or metastasis;
• 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)
• Subjects and their family members can understand the research plan, and are willing to participate, and sign an informed consent form.

You may not qualify if:

• Patients with active bleeding requiring emergency treatment;
• Patients with severe complications of CRP, such as Rectal ulcer (VRS\>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
• Patients with a history of rectal resection;
• Other bleeding diseases, such as grade III or IV hemorrhoids, coagulation dysfunction, etc.;
• Patients with other diseases requiring long-term use of anticoagulant drugs;
• Combined intestinal obstruction, requiring surgery;
• The absolute value of neutrophils of patients is lower than 750/mm3;
• Patients who are allergic to thalidomide;
• Pregnant or lactating women;
• Patients with severe mental illness;
• Patients who cannot take medication or follow up as planned;
• During the trial and within 3 months after the trial, the subjects and their partners are not willing to contraception;
• Participants in other clinical investigators 3 months before the trial

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Related Publications (11)

• 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.

  PMID: 26925655 BACKGROUND

• 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.

  PMID: 17661253 BACKGROUND

• 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.

  PMID: 16905712 RESULT

• 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.

  PMID: 23931282 RESULT

• 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.

  PMID: 27350738 RESULT

• 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.

  PMID: 18720539 RESULT

• 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.

  PMID: 11788559 RESULT

• 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.

  PMID: 18773348 RESULT

• 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.

  PMID: 15016759 RESULT

• 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.

  PMID: 28429071 RESULT

• 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.

  PMID: 25834325 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Tenghui Ma, MD

CONTACT

13560232462; matengh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thalidomide Group

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 22, 2020
• Study Start: December 14, 2020
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 22, 2020

Record last verified: 2020-12