Rectal Cancer, RadiotherapyNCT06837831
Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal Skin
A study testing Experimental group in people with Rectal Cancer, Radiotherapy and Anal Pain, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Radiotherapy, Anal Pain, Acute Radiation Dermatitis
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed rectal cancer by histopathological diagnosis;
- Individuals with clear indications for radiotherapy;
- Individuals who receive radiation therapy for the first time and develop grade 2 or higher acute radiation dermatitis after receiving radiation therapy;
- Age ≥ 18 years old;
- Those who voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Individuals with allergic constitution and allergies to the drugs and materials used in this study;
- Those who withdraw or interrupt radiotherapy midway;
- Individuals with mental illness, emotional instability, or inability to express their own feelings;
- Individuals with various comorbidities such as serious cardiovascular and cerebrovascular diseases, digestive system diseases, hematological diseases, and infectious diseases;
- Physical condition score (Eastern Cooperative Oncology Group, ECOG) >3 points;
- Individuals suffering from anal fissures and other diseases that cause skin damage to the anal canal;
- Individuals with an artificial anus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Yanwei Yang, postgraduate, +8615863788372, 15863788372@163.com
About this study
Official title: Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy: a Randomized Controlled Trial
Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Radiotherapy is one of the important methods for comprehensive treatment of rectal cancer, but the radiation damage caused by radiotherapy cannot be ignored. During radiotherapy for rectal cancer, the skin of the anal canal will be damaged by radiation, resulting in acute radiation dermatitis, which is characterized by redness, pain, and ulcers. The main symptom of patients is anal pain. As the radiation dose accumulates, the skin damage to the anal canal becomes increasingly severe, and the patient's anal pain becomes more severe, which seriously affects the patient's quality of life. Mepilex Lite Dressings can absorb the exudate, keep it moist, promote the healing of radioactive dermatitis, and relieve pain. However, when inserting into the anal canal, the patient reported significant pain that was difficult to tolerate. Therefore, indomethacin suppositories were administered rectally before inserting the dressing, which has been proven to have a reliable analgesic effect by research. In summary, the main objective of this study is to determine the effectiveness of Mepilex Lite Dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis of anal canal skin in patients with rectal cancer undergoing radiotherapy.
Method: The research plan will be a prospective randomized controlled trial. Participants were randomly divided into an experimental group (n=137) and a control group (n=137) using a simple randomization method. The control group received indomethacin suppositories and routine nursing measures, while the experimental group received the same treatment as the control group and received insertion of Meipile Lite Dressing into the anal canal. The primary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 14th day after intervention, and the secondary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 7th and 21st days after intervention. At the same time, a questionnaire survey was conducted using the Digital Pain Assessment Scale, Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Skin Disease Patient Quality of Life Scale at baseline and on the 7th, 14th, and 21st days after intervention.
Read the detailed description
Rectal cancer is a common type of cancer, and radiotherapy is an important treatment method, which is of great significance for the treatment of rectal cancer. But the adverse reactions of radiotherapy also make patients feel extremely painful. The common adverse reactions of radiotherapy for rectal cancer mainly include radiation enteritis, clinically manifested as diarrhea, abdominal pain, urgency, anal pain, etc. Among them, anal pain is very painful for patients. In clinical practice, anal pain is usually considered a normal adverse reaction of radiotherapy, and is only treated with medication to alleviate pain. After the efficacy of the medication, patients may experience pain again, especially during defecation, which seriously affects their quality of life.
Through physical examination, it was found that the tissues inside the patient's anus had been damaged or even ulcerated. This area is the anatomical anal canal, from the dentate line to the anal margin. This area is covered with non-keratinized stratified squamous epithelium and is an unnatulated skin that is extremely sensitive to pain and other conditions. As the radiation dose accumulates, the anal canal skin is continuously irradiated and damaged, resulting in acute radiation dermatitis of the anal canal skin. Therefore, the patient complains of significant pain.
In order to alleviate patients' anal pain and ensure the successful completion of radiotherapy, it was found that the mepilex lite dressings was effective in the treatment of radiation dermatitis after consulting the literature, but as far as we know, it has not been applied to the treatment of anal canal skin radiation dermatitis. Therefore, this study is a bold attempt to insert mepilex lite dressings into the anal canal to verify its effectiveness in treating anal canal skin radiation dermatitis, and whether it can reduce pain and improve the quality of life of patients.
- Being tested
- Control group, Experimental group
- Keywords
- Rectal cancer, mepilex lite dressings, indomethacin suppository, anal pain, Acute radiation dermatitis, Anal Canal
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Control group: All patients will receive routine care, including informing them to gently clean the perianal skin with warm water after each bowel movement, and gently wiping it with a cotton cloth. They will also wear loose cotton underwear to keep the perianal skin clean and dry. We will guide patients to consume high protein, high vitamin, and low fiber foods, and avoid spicy and stimulating foods,et al.On the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00).
Experimental groupCombination product
Experiment group: In addition to the control group interventions, patients received Mepilex Lite dressings inserted into the anal canal. A 30 mg indomethacin suppository was administered rectally 30 minutes before dressing placement. Patients were placed in the left lateral position with knees flexed. The anal canal was cleaned with cotton swabs moistened with 0.9% sodium chloride solution and air-dried. The anus and injured anal canal skin were exposed, and a 5 cm × 5 cm dressing was applied to the wound with the adhesive side facing the lesion. During exhalation, the dressing was gently inserted 3 cm into the anal canal with 2 cm remaining externally, ensuring full adherence to the damaged tissue. Patients were advised to rest in bed and avoid defecation. Dressings were removed the next morning and replace if dislodged prematurely.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | On the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00). Receives: Other: Control group |
| Experimental group | Experimental | In addition to the measures applied to the control group, patients in the experiment group will be given Mepilex Lite Dressings combined with Indomethacin Suppositories. Receives: Combination Product: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effective rate of anal canal skin radiation dermatitis
On the 14th day after intervention, the evaluation of the effectiveness of treatment for anal canal skin radiation dermatitis will be conducted using the RTOG acute radiation dermatitis grading standard.
Measured: From enrollment to day 14 after intervention treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Feb 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer, RadiotherapyStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heli Shang, undergraduate, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837831
- Sponsor's protocol ID
- Zlflk2025
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, data generated in later studies will be published in the form of a paper
Publications
Shang H, Yang Y, Cao H, Wu Y, Ji H. Clinical efficacy of Mepilex Lite dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis caused by rectal cancer radiotherapy: a study protocol for a randomised controlled trial. BMJ Open. 2026 Jul 30;16(7):e122248. doi: 10.1136/bmjopen-2026-122248.
PubMed 42532557
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Mepilex Lite Dressings Combined With Indomethacin Suppositories in the Treatment of Acute Radiation Dermatitis Caused by Rectal Cancer Radiotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06837831
- Acronym / sponsor ID
- Zlflk2025
- Keywords
- Rectal cancer, mepilex lite dressings, indomethacin suppository, anal pain, Acute radiation dermatitis, Anal Canal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
Background: According to GLOBOCAN 2022 statistics, colorectal cancer has become the third most common cancer disease worldwide, and also the second leading cause of death. The incidence rate of rectal cancer is particularly prominent. Radiotherapy is one of the important methods for comprehensive treatment of rectal cancer, but the radiation damage caused by radiotherapy cannot be ignored. During radiotherapy for rectal cancer, the skin of the anal canal will be damaged by radiation, resulting in acute radiation dermatitis, which is characterized by redness, pain, and ulcers. The main symptom of patients is anal pain. As the radiation dose accumulates, the skin damage to the anal canal becomes increasingly severe, and the patient's anal pain becomes more severe, which seriously affects the patient's quality of life. Mepilex Lite Dressings can absorb the exudate, keep it moist, promote the healing of radioactive dermatitis, and relieve pain. However, when inserting into the anal canal, the patient reported significant pain that was difficult to tolerate. Therefore, indomethacin suppositories were administered rectally before inserting the dressing, which has been proven to have a reliable analgesic effect by research. In summary, the main objective of this study is to determine the effectiveness of Mepilex Lite Dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis of anal canal skin in patients with rectal cancer undergoing radiotherapy.
Method: The research plan will be a prospective randomized controlled trial. Participants were randomly divided into an experimental group (n=137) and a control group (n=137) using a simple randomization method. The control group received indomethacin suppositories and routine nursing measures, while the experimental group received the same treatment as the control group and received insertion of Meipile Lite Dressing into the anal canal. The primary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 14th day after intervention, and the secondary outcome measure was the effective rate of treatment for acute radiation dermatitis of the anal canal skin on the 7th and 21st days after intervention. At the same time, a questionnaire survey was conducted using the Digital Pain Assessment Scale, Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Skin Disease Patient Quality of Life Scale at baseline and on the 7th, 14th, and 21st days after intervention.
Detailed description
Rectal cancer is a common type of cancer, and radiotherapy is an important treatment method, which is of great significance for the treatment of rectal cancer. But the adverse reactions of radiotherapy also make patients feel extremely painful. The common adverse reactions of radiotherapy for rectal cancer mainly include radiation enteritis, clinically manifested as diarrhea, abdominal pain, urgency, anal pain, etc. Among them, anal pain is very painful for patients. In clinical practice, anal pain is usually considered a normal adverse reaction of radiotherapy, and is only treated with medication to alleviate pain. After the efficacy of the medication, patients may experience pain again, especially during defecation, which seriously affects their quality of life.
Through physical examination, it was found that the tissues inside the patient's anus had been damaged or even ulcerated. This area is the anatomical anal canal, from the dentate line to the anal margin. This area is covered with non-keratinized stratified squamous epithelium and is an unnatulated skin that is extremely sensitive to pain and other conditions. As the radiation dose accumulates, the anal canal skin is continuously irradiated and damaged, resulting in acute radiation dermatitis of the anal canal skin. Therefore, the patient complains of significant pain.
In order to alleviate patients' anal pain and ensure the successful completion of radiotherapy, it was found that the mepilex lite dressings was effective in the treatment of radiation dermatitis after consulting the literature, but as far as we know, it has not been applied to the treatment of anal canal skin radiation dermatitis. Therefore, this study is a bold attempt to insert mepilex lite dressings into the anal canal to verify its effectiveness in treating anal canal skin radiation dermatitis, and whether it can reduce pain and improve the quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control groupOn the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00). |
| Experimental group | Experimental | Combination Product: Experimental groupIn addition to the measures applied to the control group, patients in the experiment group will be given Mepilex Lite Dressings combined with Indomethacin Suppositories. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed rectal cancer by histopathological diagnosis;
- Individuals with clear indications for radiotherapy;
- Individuals who receive radiation therapy for the first time and develop grade 2 or higher acute radiation dermatitis after receiving radiation therapy;
- Age ≥ 18 years old;
- Those who voluntarily participate in this study and sign the informed consent form.
Key exclusion criteria (7 listed)
- Individuals with allergic constitution and allergies to the drugs and materials used in this study;
- Those who withdraw or interrupt radiotherapy midway;
- Individuals with mental illness, emotional instability, or inability to express their own feelings;
- Individuals with various comorbidities such as serious cardiovascular and cerebrovascular diseases, digestive system diseases, hematological diseases, and infectious diseases;
- Physical condition score (Eastern Cooperative Oncology Group, ECOG) >3 points;
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 |
|---|---|---|
| Control groupControl group: All patients will receive routine care, including informing them to gently clean the perianal skin with warm water after each bowel movement, and gently wiping it with a cotton cloth. They will also wear loose cotton underwear to keep the perianal skin clean and dry. We will guide patients to consume high protein, high vitamin, and low fiber foods, and avoid spicy and stimulating foods,et al.On the basis of routine care, patients will be given 30 mg of indomethacin suppositories for rectal administration after emptying their stool and urine before bedtime (21:00). | Other | Control group |
| Experimental groupExperiment group: In addition to the control group interventions, patients received Mepilex Lite dressings inserted into the anal canal. A 30 mg indomethacin suppository was administered rectally 30 minutes before dressing placement. Patients were placed in the left lateral position with knees flexed. The anal canal was cleaned with cotton swabs moistened with 0.9% sodium chloride solution and air-dried. The anus and injured anal canal skin were exposed, and a 5 cm × 5 cm dressing was applied to the wound with the adhesive side facing the lesion. During exhalation, the dressing was gently inserted 3 cm into the anal canal with 2 cm remaining externally, ensuring full adherence to the damaged tissue. Patients were advised to rest in bed and avoid defecation. Dressings were removed the next morning and replace if dislodged prematurely. | Combination product | Experimental group |
Primary outcome
To evaluate the effective rate of anal canal skin radiation dermatitis
Time frame: From enrollment to day 14 after intervention treatment
On the 14th day after intervention, the evaluation of the effectiveness of treatment for anal canal skin radiation dermatitis will be conducted using the RTOG acute radiation dermatitis grading standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42532557Shang H, Yang Y, Cao H, Wu Y, Ji H. Clinical efficacy of Mepilex Lite dressings combined with indomethacin suppositories in the treatment of acute radiation dermatitis caused by rectal cancer radiotherapy: a study protocol for a randomised controlled trial. BMJ Open. 2026 Jul 30;16(7):e122248. doi: 10.1136/bmjopen-2026-122248.
- Individual participant dataSharing planned: Yes. The study protocol, data generated in later studies will be published in the form of a paper
Related trials for Rectal Cancer, Radiotherapy
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
Heli Shang, undergraduate study director
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Rectal Cancer, Radiotherapy and Anal Pain, run by Qianfoshan 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 7 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heli Shang, undergraduate (+8613789820123, 1197@sdhospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effective rate of anal canal skin radiation dermatitis (time frame: From enrollment to day 14 after intervention treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837831, which also lists 1 linked publication.
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 13 Apr 2026.