Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy
Conditions
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.
Interventions
OTHERprobiotics
recieving probiotics at the first day of chemoradiotherapy daily
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The random assignment of patients was performed by Nanchang Medical University with a computer-generated random number code. Patients were randomly distributed in a 1:1 ratio to receive probiotics or a placebo (the block size was known only to the statistician). The drug was distributed and packaged in accordance with random numbers, and the documents stating the parameters, such as the blinding codes for the seeds of the random numbers, the block length, and the random numbers, were sealed in envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| grade 3 entiritis | one month | Diarrhea more than seven times a day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AE | one month | Adverse drug events |
| immune index | one month | immune globulin |
| Changes in intestinal flora | one month | Dung sequencing |
Countries
China
Contacts
Primary ContactChunling Jiang, MD,PHD
Backup ContactXiaodan Chen, PHD
Outcome results
None listed