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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05406882
Other study ID # HX-H2112345
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 15, 2022
Est. completion date September 30, 2024

Study information

Verified date July 2022
Source West China Hospital
Contact xin wang, PhD/MD
Phone +86 28 85423609
Email wangxin213@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 176
Est. completion date September 30, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy. - without other malignant tumors; - Those without serious heart, liver, kidney and other diseases; - ECOG score: 0-1. Exclusion Criteria: - Complicated with ulcerative colitis or Crohn's disease; - Complicated with severe organ insufficiency, severe diabetes, and heart disease; - Pregnant and lactating women; - Abnormal bowel movements with systemic and metabolic diseases; - The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.

Study Design


Intervention

Drug:
Live Combined Bifidobacterium and Lactobacillus Tablets?Compound Glutamine Entersoluble capsules
Live Combined Bifidobacterium and Lactobacillus Tablets:probiotics. Compound Glutamine Entersoluble capsules:combined traditional Chinese medicine and glutamine

Locations

Country Name City State
China West China Hospital Chengdu Sichuan
China Xin Wang Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale 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
Other 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
Other 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
Other Changes in serum inflammatory factors Assess changes in serum inflammatory factors , including IL-2?IL-6,CRP?TNFa, etc. two months
Other 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
Other 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
Other 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
Primary Incidence of radiation proctitis Incidence of grade =2 radiation proctitis in combination therapy group two months
Secondary remission rate of radiation proctitis remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade =2 two months
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