An interventional study of probiotics in Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy, sponsored by Jiangxi Provincial Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Jiangxi Provincial Cancer Hospital · Not applicable, Interventional, and Prevention
Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.
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.
82 studies on the registry are indexed under Pelvic Neoplasms; 28 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 50 interventional studies indexed under Pelvic Neoplasms.
Browse Pelvic Neoplasms studies →Jiangxi Provincial Cancer Hospital is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention
Other: probiotics
placebo( one times a day)with radiotherapy and Chemotherapy Intervention
healthy control group
recieving probiotics at the first day of chemoradiotherapy daily
grade 3 entiritis
Diarrhea more than seven times a day
Time frame: one month
AE
Adverse drug events
Time frame: one month
immune index
immune globulin
Time frame: one month
Changes in intestinal flora
Dung sequencing
Time frame: one month
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Jiangxi Provincial Cancer Hospital