KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

Summary

This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are: 1. Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment? 2. Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)? 3. What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location. Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis: 1. Change in LENT-SOMA rectal injury score (baseline vs. 3 months). 2. Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores. 3. Symptom improvement rate and time to complete remission. Participant will: 1. Undergo baseline and 3-month endoscopic evaluations. 2. Complete symptom diaries and quality-of-life questionnaires. 3. Attend regular clinic visits for safety monitoring.

Timeline

Start

2025-08

Primary completion

2029-01

Completion

2029-01

Publications

• Background Zhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4.
• Background Tohidinezhad F, Willems Y, Berbee M, Limbergen EV, Verhaegen F, Dekker A, Traverso A. Prediction models for brachytherapy-induced rectal toxicity in patients with locally advanced pelvic cancers: a systematic review. J Contemp Brachytherapy. 2022 Aug;14(4):411-422. doi: 10.5114/jcb.2022.119427. Epub 2022 Aug 31.
• Background Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.
• Background Wang CJ, Huang EY, Sun LM, Chen HC, Fang FM, Hsu HC, Changchien CC, Leung SW. Clinical comparison of two linear-quadratic model-based isoeffect fractionation schemes of high-dose-rate intracavitary brachytherapy for cervical cancer. Int J Radiat Oncol Biol Phys. 2004 May 1;59(1):179-89. doi: 10.1016/j.ijrobp.2003.10.025.

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Indications