A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy

The goal of this clinical trial is to reduce the acute hemorrhoids-related symptoms for cervical cancer patients with hemorrhoids who need postoperative pelvic radiation therapy, including prolapse, local burning, bleeding, perianal pain, and other perianal discomforts. The main questions it aims to answer are: Will anal canal-sparing technique improve the quality of life for cervical cancer patients with hemorrhoids during pelvic radiation therapy? Will the radiation dose exposure to anal canal be reduced through anal canal-sparing technique? Researchers will compare the aggravation of radiation-induced hemorrhoids-related symptoms occurring from the initiation of pelvic radiation therapy until 4 weeks after its completion. Conventional postoperative treatment regimens will not be changed and researchers will only reduce the irradiated dose to anal canal which should be protected during pelvic radiation therapy. Participants will be randomly assigned with equal probability (1:1 ratio) to either: control group (conventional postoperative pelvic radiation therapy) and intervention group (anal canal-sparing pelvic radiation therapy), in either combined with brachytherapy or not. Following randomization, participants will not be informed of their group assignment until completion of the follow-up period. Notice: The treatment efficacy will not be compromised by group assignment. No additional treatment-related adverse effects will occur due to study participation. The intervention group may potentially mitigate radiotherapy-induced adverse effects.

NCT Number	NCT07175584
Lead Sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Collaborators: RenJi Hospital, Suzhou Municipal Hospital, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University
Conditions	Hemorrhoidal Disease, Cervical Cancer Radiation Complications
Enrollment	300 participants
Start Date	2025-09-29
Primary Completion	2027-09-28 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-22