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

Jiangxi Provincial Cancer Hospital

Status: Enrolling

Conditions: Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy

Treatments: Other: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05032027

JCL2021-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups

Probiotic group

Experimental group

Description:

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

Treatment:

Other: probiotics

placebo group

No Intervention group

Description:

placebo( one times a day)with radiotherapy and Chemotherapy Intervention

healthy control group

No Intervention group

Description:

healthy control group