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

Sponsor

Jiangxi Provincial Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05032027

Collaborator

(none)

Enrollment

Location

Arms

39.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy	Other: probiotics	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy

Anticipated Study Start Date :

Aug 27, 2021

Anticipated Primary Completion Date :

Dec 27, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic group Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention	Other: probiotics recieving probiotics at the first day of chemoradiotherapy daily
No Intervention: placebo group placebo( one times a day)with radiotherapy and Chemotherapy Intervention
No Intervention: healthy control group healthy control group

Arm

Intervention/Treatment

Experimental: Probiotic group

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

Other: probiotics

recieving probiotics at the first day of chemoradiotherapy daily

No Intervention: placebo group

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

No Intervention: healthy control group

healthy control group

Outcome Measures

Primary Outcome Measures

grade 3 entiritis [one month]
Diarrhea more than seven times a day

Secondary Outcome Measures

AE [one month]
Adverse drug events
immune index [one month]
immune globulin
Changes in intestinal flora [one month]
Dung sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China	330029

Sponsors and Collaborators

Jiangxi Provincial Cancer Hospital

Investigators

Principal Investigator: Chunling Jiang, MD,PHD, radiation department of Jiangxi cancer hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangxi Provincial Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05032027

Other Study ID Numbers:

JCL2021-1

First Posted:

Sep 2, 2021

Last Update Posted:

Sep 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Neoplasms

Enteritis

Study Results

No Results Posted as of Sep 2, 2021