Chronic Radiation ProctitisPhase 2Thal-CRPNCT04680195
Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
A Phase 2 study testing Thalidomide in people with Chronic Radiation Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Radiation Proctitis
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2020to 30 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Open Clinical Trial of Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
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.
Read the detailed description
Radiotherapy is an essential therapeutic tool for pelvic malignancies such as uterine cervix, uterine corpus, prostate, testicular, urinary bladder and rectal cancers. According to reports, the estimated number of new cases of malignant pelvic tumors in China in 2015 alone exceeded 500,000. Chronic radiation proctitis (CRP) is an unavoidable and commonly observed side effect, occurs 3 months later and in 5-20% of patients after pelvic malignancy radiation. Hematochezia is the most common symptom for more than 80% of CRP patients, which is a persistent, irreversible and progressive symptom, and will probably give rise to anemia. In clinic, the treatment for intractable bleeding of CRP is very difficult.
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
- Chronic Radiation Proctitis
- Being tested
- Thalidomide
- Keywords
- Thalidomide, Bleeding, Chronic radiation proctitis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide treatment Group | Experimental | Induction period:
Thalidomide tablets: 50-100 mg/d, qn, po.
Maintenance period:
Thalidomide tablets: 50-75 mg/d qn, po. Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first month after thalidomide treatment
Secondary outcomes (20)
Remission rate of rectal bleeding one month during 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.
Measured: the first month during thalidomide treatment
Remission rate of rectal bleeding two months during 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.
Measured: the second month during thalidomide treatment
Remission rate of rectal bleeding three months during 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.
Measured: the third month during thalidomide treatment
Remission rate of rectal bleeding four months during 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.
Measured: the fourth month during thalidomide treatment
Remission rate of rectal bleeding three months 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.
Measured: the third month after thalidomide treatment
Remission rate of rectal bleeding six months 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.
Measured: the sixth month after thalidomide treatment
Endoscopic score one month during thalidomide treatment
Endoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
Measured: the first month during thalidomide treatment
Endoscopic score four months during thalidomide treatment
Endoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
Measured: the fourth month during thalidomide treatment
Endoscopic score one month after thalidomide treatment
Endoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
Measured: the first month after thalidomide treatment
Endoscopic score three months after thalidomide treatment
Endoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
Measured: the third month after thalidomide treatment
Endoscopic score six months after thalidomide treatment
Endoscopic score was performed using Vienna rectoscopy Score (VRS). VRS was ranged 1 to 5. A higher score indicated a more severe lesion.
Measured: the sixth month after thalidomide treatment
Quality of life of the patient one month during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the first month during thalidomide treatment
Quality of life of the patient two months during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the second month during thalidomide treatment
Quality of life of the patient three months during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the third month during thalidomide treatment
Quality of life of the patient four months during thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the fourth month during thalidomide treatment
Quality of life of the patient one month after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the first month after thalidomide treatment
Quality of life of the patient three months after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the third month after thalidomide treatment
Quality of life of the patient six months after thalidomide treatment
Quality of life of the patient was evaluated by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 was a 30-item questionnaire composed of multi-item scales and single items that reflecting the multidimensionality of the quality-of-life. It incorporated five functioning subscales (physical, role, cognitive, emotional, and social), nine symptom subscales (pain, fatigue, nausea and vomiting, appetite loss, constipation, diarrhea, dyspnea, insomnia, financial difficulties), and one global quality of life subscale, and the scores were ranged 0 to 100. Higher scores for functional subscales and global quality of life subscale indicated the better functional status and quality of life. But the higher scores for symptom subscales indicated the poorer quality of life.
Measured: the sixth month after thalidomide treatment
Incidence of adverse events four months during thalidomide treatment
Including adverse reactions of thalidomide and other adverse events
Measured: the fourth month during thalidomide treatment
Incidence of adverse events six months after thalidomide treatment
Including adverse reactions of thalidomide and other adverse events
Measured: the sixth month after thalidomide treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start14 Dec 2020 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thalidomide Group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680195
- Sponsor's protocol ID
- HOPE2020-Thal-CRP
- Acronym
- Thal-CRP
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26925655Andreyev 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.
PubMed 17661253Craanen 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.
PubMed 16905712Zhou 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.
PubMed 23931282Yuan 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.
PubMed 27350738Kim 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.
PubMed 18720539Bauditz 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.
PubMed 11788559Alberto 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.
PubMed 18773348Bauditz 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.
PubMed 15016759McCrone 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.
PubMed 28429071Ma 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.
PubMed 25834325
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Clinical Trial of Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
- ClinicalTrials.gov ID
- NCT04680195
- Acronym / sponsor ID
- Thal-CRP / HOPE2020-Thal-CRP
- Conditions
- Chronic Radiation Proctitis
- Keywords
- Thalidomide, Bleeding, Chronic radiation proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Dec 2020 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiotherapy is an essential therapeutic tool for pelvic malignancies such as uterine cervix, uterine corpus, prostate, testicular, urinary bladder and rectal cancers. According to reports, the estimated number of new cases of malignant pelvic tumors in China in 2015 alone exceeded 500,000. Chronic radiation proctitis (CRP) is an unavoidable and commonly observed side effect, occurs 3 months later and in 5-20% of patients after pelvic malignancy radiation. Hematochezia is the most common symptom for more than 80% of CRP patients, which is a persistent, irreversible and progressive symptom, and will probably give rise to anemia. In clinic, the treatment for intractable bleeding of CRP is very difficult.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thalidomide Group
| Arm | Type | Receives |
|---|---|---|
| Thalidomide treatment Group | Experimental | Drug: ThalidomideInduction period: Thalidomide tablets: 50-100 mg/d, qn, po. Maintenance period: Thalidomide tablets: 50-75 mg/d qn, po. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThalidomideThe 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. | Drug | Thalidomide treatment Group |
Primary outcome
Remission rate of rectal bleeding one month after thalidomide treatment
Time frame: the first 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.
20 secondary outcomes
Remission rate of rectal bleeding one month during thalidomide treatment
Time frame: the first month during thalidomide treatment
Remission rate of rectal bleeding two months during thalidomide treatment
Time frame: the second month during thalidomide treatment
Remission rate of rectal bleeding three months during thalidomide treatment
Time frame: the third month during thalidomide treatment
Remission rate of rectal bleeding four months during thalidomide treatment
Time frame: the fourth month during thalidomide treatment
Remission rate of rectal bleeding three months after thalidomide treatment
Time frame: the third month after thalidomide treatment
Remission rate of rectal bleeding six months after thalidomide treatment
Time frame: the sixth month after thalidomide treatment
Endoscopic score one month during thalidomide treatment
Time frame: the first month during thalidomide treatment
Endoscopic score four months during thalidomide treatment
Time frame: the fourth month during thalidomide treatment
Endoscopic score one month after thalidomide treatment
Time frame: the first month after thalidomide treatment
Endoscopic score three months after thalidomide treatment
Time frame: the third month after thalidomide treatment
Endoscopic score six months after thalidomide treatment
Time frame: the sixth month after thalidomide treatment
Quality of life of the patient one month during thalidomide treatment
Time frame: the first month during thalidomide treatment
Quality of life of the patient two months during thalidomide treatment
Time frame: the second month during thalidomide treatment
Quality of life of the patient three months during thalidomide treatment
Time frame: the third month during thalidomide treatment
Quality of life of the patient four months during thalidomide treatment
Time frame: the fourth month during thalidomide treatment
Quality of life of the patient one month after thalidomide treatment
Time frame: the first month after thalidomide treatment
Quality of life of the patient three months after thalidomide treatment
Time frame: the third month after thalidomide treatment
Quality of life of the patient six months after thalidomide treatment
Time frame: the sixth month after thalidomide treatment
Incidence of adverse events four months during thalidomide treatment
Time frame: the fourth month during thalidomide treatment
Incidence of adverse events six months after thalidomide treatment
Time frame: the sixth month after thalidomide treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 26925655Yuan 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.
- Background: PubMed 17661253Andreyev 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.
- Results publication: PubMed 16905712Craanen 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.
- Results publication: PubMed 23931282Zhou 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.
- Results publication: PubMed 27350738Yuan 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.
- Results publication: PubMed 18720539Kim 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.
- Results publication: PubMed 11788559Bauditz 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.
- Results publication: PubMed 18773348Alberto 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.
- Results publication: PubMed 15016759Bauditz 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.
- Results publication: PubMed 28429071McCrone 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.
- Results publication: PubMed 25834325Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Chronic Radiation Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tenghui Ma, MD (13560232462, matengh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of rectal bleeding one month after thalidomide treatment (time frame: the first month after thalidomide treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680195, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.