Clinical trial · Interventional
A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy
Anal Canal-Sparing Technique During Postoperative Pelvic Radiation Therapy for Cervical Cancer Patients to Reduce Hemorrhoids-related Symptoms: A Multicenter Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Radiation Complications | — | UNRESOLVED | — |
| Hemorrhoidal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anal canal-sparing techniques | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anal Canal-Sparing Arm
- description
- Participants will receive pelvic radiation therapy using anal canal-sparing techniques. There will be 150 participants enrolled.
- interventionNames
- Radiation: anal canal-sparing techniques
- type
- NO_INTERVENTION
- label
- Conventional Radiation therapy Arm
- description
- Participants will receive pelvic radiation therapy using standard techniques. There will be 150 participants enrolled.
Primary outcomes (1)
- measure
- The incidence of radiation-induced hemorrhoid-related symptoms
- timeFrame
- From the initiation of pelvic radiation therapy (including BT) until 4 weeks after its completion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Treated with hysterectomy (including total abdominal hysterectomy, vaginal hysterectomy, radical hysterectomy, or laparoscopically assisted vaginal hysterectomy) within 6 weeks prior to study initiation. * Histologically proven diagnosis of cervical carcinoma, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * Requirement for postoperative adjuvant concurrent chemoradiotherapy (CCRT). * Age \> 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * History of hemorrhoids prior to radiotherapy, with no hemorrhoid-related symptoms for at least 4 weeks before radiation therapy initiation. * Abdominal/pelvic MRI, chest CT, or PET-CT performed before surgery or study enrollment to confirm staging and exclude patients with distant metastasis. * Adequate bone marrow, renal, and hepatic function. * Agreement to undergo anal canal MRI before radiation therapy initiation. * Patient must provide study-specific informed consent form (ICF) prior to study entry. Exclusion Criteria: * Cervical cancer patients who do not meet the criteria for adjuvant radiation therapy. * Without a confirmed history of hemorrhoids. * Patients contraindicated for MRI (e.g., due to incompatible metallic implants, claustrophobic syndrome, or other contraindications). * Patients who refuse to undergo anal canal MRI. * Patients with radiographically visible residual disease post-surgery requiring boost during the pelvic EBRT. * History of other malignancies. * Prior pelvic radiotherapy resulting in overlapping radiation fields. * History of allergic reaction to platinum-based chemotherapy agents. * Severe and/or active comorbidities precluding tolerance of concurrent chemoradiotherapy.
References
Publications (0)
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