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Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy group | Experimental | From the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. |
|
| control group | No Intervention | After the start of chemoradiotherapy, the control group don't take the experimental drug orally . When patients have radiation proctitis of grade ≥2, they would be crossed over to the combined treatment group:live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules | Drug | Live Combined Bifidobacterium and Lactobacillus Tablets:probiotics. Compound Glutamine Entersoluble capsules:combined traditional Chinese medicine and glutamine |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiation proctitis | Incidence of grade ≥2 radiation proctitis in combination therapy group | two months |
| Measure | Description | Time Frame |
|---|---|---|
| remission rate of radiation proctitis | remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2 | two months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of radiation proctitis by LENT SOMA Score | Evaluation of radiation proctitis with clinical symptoms using LENT SOMA Score.The minimum value is 0, and maximum is 4. Higher scores mean a worse outcome. | two months |
| Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xin wang, PhD/MD | Contact | +86 28 85423609 | wangxin213@sina.com | |
| min ren, PhD/MD | Contact | +86 28 85423609 | renmin0502@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xin wang | China, SiChuan West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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Evaluation of radiation proctitis with clinical symptoms using rectal chemoradiotherapy toxicity scale.The minimum value is 0, and maximum is 5. Higher scores mean a worse outcome. |
| two months |
| Evaluation of radiation proctitis by fiberoptic proctoscopy | Evaluation of radiation proctitis with fiberoptic proctoscopy using Vienna Rectoscopy Score. The minimum value is 0, and maximum is 3/4. Higher scores mean a worse outcome. | two months |
| changes in gut microbiota by 16S rRNA sequencing technology | To detect changes in gut microbiota with 16S rRNA sequencing,including changes in species diversity and abundance of gut microbiota. | two months |
| Changes in serum inflammatory factors | Assess changes in serum inflammatory factors , including IL-2、IL-6,CRP、TNFa, etc. | two months |
| QOL C29 | Assess patients' subjective feeling of life using EORTC QOL C29.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome. | two months |
| QOL C30 | Assess patients' subjective feeling of life using EORTC QOL C30.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome. | two months |
| tumor imaging assessment | Evaluation of tumor changes with imaging methods,including treatment response with complete response, partial response or stable disease according to RECIST 1.1 after 1 month after concurrent chemoradiotherapy. | two months |
| Xin Wang | Recruiting | Chengdu | Sichuan | 610041 | China |
|