Pelvic Cancer, Enteritis, Probiotics,ChemoradiotherapyprobioticsNCT05032027
Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
A study testing probiotics in people with Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy
- What is being tested?
- probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center
Who cannot join
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Xiaodan Chen, MD, +8615270865798, chenxiaodan@163.com
About this study
Official title: A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
Effect of Probiotics on Raditon Enteritis in Pelvic Tumor Patients Receiving Radiotherapy.
Read the 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.
- Being tested
- probiotics
- Medical subject headings
- Pelvic Neoplasms, Enteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsOther
recieving probiotics at the first day of chemoradiotherapy daily
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention Receives: Other: probiotics |
| placebo group | No intervention | placebo( one times a day)with radiotherapy and Chemotherapy Intervention |
| healthy control group | No intervention | healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade 3 entiritis
Diarrhea more than seven times a day
Measured: one month
Secondary outcomes (3)
AE
Adverse drug events
Measured: one month
immune index
immune globulin
Measured: one month
Changes in intestinal flora
Dung sequencing
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start27 Aug 2021 (estimated)
- Primary completion27 Dec 2022 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Cancer, Enteritis, Probiotics,ChemoradiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunling Jiang, MD,PHD, Principal investigator, radiation department of Jiangxi cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032027
- Sponsor's protocol ID
- JCL2021-1
- Acronym
- probiotics
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05032027
- Acronym / sponsor ID
- probiotics / JCL2021-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 27 Aug 2021 (estimated)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Other: probioticsProbiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention |
| placebo group | No intervention | –placebo( one times a day)with radiotherapy and Chemotherapy Intervention |
| healthy control group | No intervention | –healthy control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center
Key exclusion criteria (1 listed)
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probioticsrecieving probiotics at the first day of chemoradiotherapy daily | Other | Probiotic group |
Primary outcome
grade 3 entiritis
Time frame: one month
Diarrhea more than seven times a day
3 secondary outcomes
AE
Time frame: one month
immune index
Time frame: one month
Changes in intestinal flora
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunling Jiang, MD,PHD principal investigator
radiation department of Jiangxi cancer hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Pelvic Cancer, Enteritis, Probiotics,Chemoradiotherapy, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang, MD,PHD (+8613979109200, jclil2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade 3 entiritis (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.