Clinical Research Directory

Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal Skin

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.

SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC

This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.

Walking and Sitting Difficulties After Rectal Cancer Surgery

Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic. WASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part. The patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity. The idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.

PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging

This is a study focused on analyses of peripheral blood (tissue study). The aim of the trial is to determine whether it is possible to predict early clinical and/or pathological responses after radiotherapy in the setting of neoadjuvant treatment for locally advanced rectal carcinomas, through qualitative and quantitative assessment of circulating extracellular vesicles in plasma and the microRNA (miRNA) contained within them. Extracellular vesicles are "clean-up" structures that collect various elements circulating in the blood, including fragments of DNA and RNA from tumor cells. Observing how these structures and their contents change with radiotherapy could provide early indications of the tumor's response to treatment. The trial seeks to answer the question: "Can the quantity of CD69+ vesicles in patients undergoing neoadjuvant radiotherapy predict their response early?" The trial is monocentric and plans to enroll approximately 30 patients. Participation in this trial does not offer direct benefits, as it involves only laboratory investigations without modifications to the usual diagnostic-therapeutic process for the condition considered. The collection of information is aimed at improving knowledge regarding extracellular vesicles. These vesicles could provide early insights into the response to neoadjuvant radiotherapy for locally advanced rectal tumors. In this way, subsequent therapeutic strategies can be personalized based on this response.