Oral MucositisNCT05059613
Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
A study testing probiotics in people with Oral Mucositis and Quality of Life, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
Study on the application of thalidomide with or without probiotics in radioactive oral mucositis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis, Quality of Life
- 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
- 20 Sep 2021to 31 Dec 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center
Who cannot join
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Chunling Jiang, MD phd
About this study
Official title: Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
Study on the application of thalidomide with or without probiotics in radioactive oral mucositis
Read the detailed description
Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.
- Conditions
- Oral Mucositis, Quality of Life
- Being tested
- probiotics
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsOther
one times a day during the whole treatment
| Study group | Role | What they receive |
|---|---|---|
| probiotics group | Experimental | Use thalidomide in combination with probiotics during radiotherapy and chemotherapy Receives: Other: probiotics |
| thalidomide group | No intervention | Thalidomide is used only during radiotherapy and chemotherapy |
| 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.
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Radiation oral mucositis
Measured: one month
the variaty of immune index
CD3,CD4,CD8
Measured: one month
the variaty of immune index
Hemoglobin
Measured: one month
the variaty of immune index
lymphocyte ratio
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 posted28 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059613
- Sponsor's protocol ID
- jcl2021-8
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 28 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
- ClinicalTrials.gov ID
- NCT05059613
- Acronym / sponsor ID
- jcl2021-8
- Conditions
- Oral Mucositis, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 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.
Study on the application of thalidomide with or without probiotics in radioactive oral mucositis
Detailed description
Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.
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 |
|---|---|---|
| probiotics group | Experimental | Other: probioticsUse thalidomide in combination with probiotics during radiotherapy and chemotherapy |
| thalidomide group | No intervention | –Thalidomide is used only during radiotherapy and chemotherapy |
| healthy control group | No intervention | –healthy control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center
Key exclusion criteria (1 listed)
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease
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 |
|---|---|---|
| probioticsone times a day during the whole treatment | Other | probiotics group |
Primary outcome
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Time frame: one month
Radiation oral mucositis
the variaty of immune index
Time frame: one month
CD3,CD4,CD8
the variaty of immune index
Time frame: one month
Hemoglobin
the variaty of immune index
Time frame: one month
lymphocyte ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Recruiting
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain
RecruitingPhase 3
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
Head & Neck Cancer, Oral Mucositis
Not yet recruiting
Prevention of Oral Mucositis in Adults in With Hematologic Malignancy
Acute Leukemia, Acute Myeloid Leukemia
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
Jiangxi Provincial 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 Oral Mucositis and Quality of Life, 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 28 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 (13979109200, jclil2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Radiation Therapy Oncology Group grade 3 mucositis (time frame: one month). The study lists 4 primary outcomes in all. 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 28 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.