Status:
NOT_YET_RECRUITING
A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
RenJi Hospital
Suzhou Municipal Hospital
Conditions:
Hemorrhoidal Disease
Cervical Cancer Radiation Complications
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
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, l...
Detailed Description
Radiation therapy (RT) is a main treatment method to improves local control and overall survival for cervical cancer patients with high-risk factors. External beam radiation therapy (EBRT) is particul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07175584
Start Date
September 29 2025
End Date
December 31 2027
Last Update
September 22 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080