Radiation InjuriesNCT06325982
Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
A study testing Triethanolamine cream in people with Radiation Injuries and Rectal Diseases, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Injuries, Rectal Diseases
- What is being tested?
- Triethanolamine cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
- ECOG score 0-1;
- normal mind, clear consciousness;
- High compliance;
- Able to cooperate with the interviewer
Who cannot join
- Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
- Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
- serious heart, brain, liver, kidney disease;
- Long-term immune dysfunction;
- Pregnant or lactating women;
- Patients who terminate treatment for various reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
yimin li
About this study
Official title: Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.
Read the detailed description
The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.
- Conditions
- Radiation Injuries, Rectal Diseases
- Being tested
- Triethanolamine cream
- Medical subject headings
- Radiation Injuries, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triethanolamine creamDrug
Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months.
Preparation method: Pull out the syringe piston, add 15ml triethanolamine cream, add 30ml normal saline, gently pat, shake well.
Specific methods of retention enema: at night before going to bed, empty urine and feces, prepare enema liquid into the syringe, connect the special catheter, and insert the other end of the special catheter into the anus (the special catheter can be applied with lubricant such as tea oil before insertion). The patient remained prone and semi-seated. Use a special catheter, insert a special catheter about 15cm from the anus, and inject enteral liquid while withdrawing, so that the liquid is retained in the rectum; The above treatment was performed before bed and retained overnight.
| Study group | Role | What they receive |
|---|---|---|
| Triethanolamine cream group | Experimental | Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months Receives: Drug: Triethanolamine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence time of acute and chronic radiation rectal injury
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The time (days) of acute radiation rectal injury were evaluated and recorded
Measured: Up to approximately 4 months
Evaluation of acute and chronic radiation rectal injury
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The grading of acute radiation rectal injury were evaluated and recorded
Measured: Up to approximately 4 months
Secondary outcomes (2)
Clinical symptom assessment
Clinical symptoms were assessed using the Simple Clinical Colitis Activity Index (SCCAI) designed by the Inflammatory Bowel Disease Research Group at the Royal Free Hospital School of Medicine.
SCCAI in this study included 6 items, with a total score of 0-16. The higher the score, the more severe the symptoms.
Measured: Up to approximately 4 months
Quality of life assessment assessed by IBDQ
The quality of life index (IBDQ) was used to evaluate the quality of life of patients with inflammatory bowel disease.
IBDQ included 32 questions in 4 aspects: intestinal symptoms (10), systemic symptoms (5), emotional ability (12) and social ability (5). Each question was divided into 7 grades, with a total score of 32-224 points. The higher the score, the better the quality of life. Scores above 177 indicate light, 176-121 indicate medium, and below 120 indicate heavy.
Measured: Up to approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start11 Jun 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- lingdong Shao, Bachelor, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325982
- Sponsor's protocol ID
- BYFFL-01
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06325982
- Acronym / sponsor ID
- BYFFL-01
- Conditions
- Radiation Injuries, Rectal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 11 Jun 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.
Detailed description
The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triethanolamine cream group | Experimental | Drug: Triethanolamine creamTriethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
- ECOG score 0-1;
- normal mind, clear consciousness;
- High compliance;
- Able to cooperate with the interviewer
Key exclusion criteria (6 listed)
- Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
- Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
- serious heart, brain, liver, kidney disease;
- Long-term immune dysfunction;
- Pregnant or lactating women;
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 |
|---|---|---|
| Triethanolamine creamTriethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months. Preparation method: Pull out the syringe piston, add 15ml triethanolamine cream, add 30ml normal saline, gently pat, shake well. Specific methods of retention enema: at night before going to bed, empty urine and feces, prepare enema liquid into the syringe, connect the special catheter, and insert the other end of the special catheter into the anus (the special catheter can be applied with lubricant such as tea oil before insertion). The patient remained prone and semi-seated. Use a special catheter, insert a special catheter about 15cm from the anus, and inject enteral liquid while withdrawing, so that the liquid is retained in the rectum; The above treatment was performed before bed and retained overnight. | Drug | Triethanolamine cream group |
Primary outcome
Occurrence time of acute and chronic radiation rectal injury
Time frame: Up to approximately 4 months
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The time (days) of acute radiation rectal injury were evaluated and recorded
Evaluation of acute and chronic radiation rectal injury
Time frame: Up to approximately 4 months
RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The grading of acute radiation rectal injury were evaluated and recorded
2 secondary outcomes
Clinical symptom assessment
Time frame: Up to approximately 4 months
Quality of life assessment assessed by IBDQ
Time frame: Up to approximately 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
lingdong Shao, Bachelor study chair
Fujian 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 Triethanolamine cream in people with Radiation Injuries and Rectal Diseases, run by Fujian 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 5 inclusion and 6 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 5 Jun 2024. 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 lingdong Shao, Bachelor (13905914564 ext. 0591-83660063, 1065900966@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence time of acute and chronic radiation rectal injury (time frame: Up to approximately 4 months). The study lists 2 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 5 Jun 2024.