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Mepilex Lite and indomethacin suppositories for anal canal skin radiation dermatitis trial plannedDressings Plus Suppositories May Ease Radiation Skin Pain

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Key Takeaway
Note that this is a study protocol; results regarding treatment efficacy and safety are not yet available.

The proposed randomized controlled trial aims to evaluate the treatment efficiency of acute radiation dermatitis of the anal canal skin in patients undergoing radiotherapy for rectal cancer. The study will enroll 274 patients at the First Affiliated Hospital of Shandong First Medical University.

The intervention group will receive Mepilex Lite dressings combined with indomethacin suppositories (30 mg). The comparator group will receive indomethacin suppositories (30 mg) alone. The primary outcome is measured on the 14th day after the intervention, while secondary outcomes include assessments at 7 and 21 days.

Secondary outcomes include pain scores via Numeric Rating Scale, depression and anxiety using Hospital Anxiety and Depression Scale, sleep quality via Pittsburgh Sleep Quality Index, and quality of life via Skin Disease Patient Quality of Life Scale-16. Safety data, including adverse events and tolerability, are not yet reported.

As this is a study protocol, no results are currently available to inform clinical practice. The trial aims to determine if the addition of Mepilex Lite dressings improves outcomes compared to indomethacin alone for anal canal skin radiation dermatitis.

A new study is planned to test a possible way to ease a painful side effect of radiation therapy for rectal cancer. The study will look at acute radiation dermatitis, which is skin irritation and damage in the anal area caused by radiation. The researchers want to see if using a special foam dressing called Mepilex Lite along with an indomethacin suppository works better than the suppository alone.

The study will include 274 patients who have this skin problem after radiation for rectal cancer. Participants will be split into two groups: one gets the dressing plus the suppository, and the other gets just the suppository. The main goal is to check how well the treatment works 14 days after it starts. They will also check at 7 and 21 days, and look at pain, mood, sleep, and quality of life.

It's important to note that this is a study protocol, meaning the study hasn't been done yet. No results are available, so we don't know if the combination works or if it's safe. The researchers plan to collect information on side effects, but none are reported yet.

For now, this is an early step. If the study goes well, it could offer a new option for managing radiation skin irritation. But until results come in, patients should talk to their doctors about the best way to manage their symptoms.

What this means for you:
A planned trial will test a new dressing for radiation skin irritation, but results aren't available yet.

Common questions

What is this study about?

This study is a plan for a clinical trial. It will test if using a special dressing called Mepilex Lite along with an indomethacin suppository helps treat skin irritation from radiation in rectal cancer patients. The study has not started yet, so there are no results.

Who can participate in this study?

The study plans to include 274 patients who have acute radiation dermatitis of the anal canal skin caused by radiation therapy for rectal cancer. The study is set at the First Affiliated Hospital of Shandong First Medical University.

What are the possible side effects?

The study protocol does not report any side effects yet. The researchers plan to monitor for adverse events, but no information is available at this time. Patients should discuss potential risks with their doctor.

Study Details

Study typeRct
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
INTRODUCTION: Acute radiation dermatitis is a common adverse reaction in radiotherapy, especially in patients with rectal cancer undergoing radiotherapy. At present, acute radiation dermatitis of the perianal skin has received widespread attention; however, acute radiation skin injury of the anal canal skin has not received sufficient attention. These patients mainly complain of anal pain, which seriously affects their quality of life. Mepilex Lite dressings have been recommended for the treatment of acute radiation dermatitis and have a definite effect. However, there is limited research on the use of this dressing for the treatment of acute radiation-induced dermatitis of the anal canal skin and its clinical efficacy and safety in this context need further verification. METHODS AND ANALYSIS: This study is an assessor-blinded randomised controlled trial designed to evaluate the efficacy and safety of Mepilex Lite dressings combined with indomethacin suppositories for the treatment of acute radiation dermatitis of the anal canal skin. A total of 274 eligible patients from the tumour radiotherapy ward of the First Affiliated Hospital of Shandong First Medical University will be randomly assigned to either the experiment or control group (1:1). The control group will be given 30 mg of indomethacin suppositories for rectal administration, and the experiment group will be given Mepilex Lite dressings in addition to the measures taken by the control group. The 5 cm × 5 cm dressing will be inserted into the anal canal for 3 cm through the anus and exposed for 2 cm. The main outcome indicator is the treatment efficiency of the acute radiation dermatitis of the anal canal skin on the 14th day after the intervention. The secondary outcome indicator is the treatment efficiency of the acute radiation dermatitis of the anal canal skin on the seventh and 21st days after the intervention. Concurrently, the Numeric Rating Scale, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index and Skin Disease Patient Quality of Life Scale-16 will be used to assess patient pain, depression and anxiety, sleep quality and quality of life, respectively. A table questionnaire survey will be conducted at baseline and on 7, 14 and 21 days after intervention. ETHICS AND DISSEMINATION: The research protocol has obtained ethical approval from the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (approval number: YXLL-KY-2024 (162)). The results will be published in peer-reviewed journals and abstracts will be submitted to domestic and international conferences to disseminate our research findings. TRIAL REGISTRATION NUMBER: NCT06837831.
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