Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy

Not Applicable

Recruiting

• Conditions: Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy
• Interventions: Other: probiotics

• Registration Number: NCT05032027
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

Brief Summary

Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.

Detailed Description

Radiation-induced enteritis is an common and severe side effect of the patients undergoing pelvic radiotherapy. It can lead to dose-limiting and debilitating treatment effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In previous study, we have abserved that a probiotic combination significantly enhances the immune response of patients and reduces the severity of oral mucositis through modification of gut microbiota. In this stuyd we plan to designe a randomized trial of Probiotics probiotics in patients with pelvic carcinoma.The aim of this study is to determine if regulating intestinal tract flora will reduce the severity of radiation-induced mucositis in patients receiving pelvic radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of grade 3 enteritis. In 2021, 40 patients are estimated to be recruited into the study in Jiangxi Cancer Hospitals, China. 20 patients were randomized to receive Probiotics or placebo during chemoradiotherapy respectively.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-23
• Study Start: 2021-08-27
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-12-27
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center

Exclusion Criteria

• any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	probiotics	Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention

Primary Outcome Measures

Name	Time	Method
grade 3 entiritis	one month	Diarrhea more than seven times a day

Secondary Outcome Measures

Name	Time	Method
AE	one month	Adverse drug events
immune index	one month	immune globulin
Changes in intestinal flora	one month	Dung sequencing

Trial Locations

Locations (1)

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China