NCT07175584Not yet recruiting
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 · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 29 Sept 2025
- Primary completion date
- 28 Sept 2027
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Cervical cancer
- NCT number
- NCT07175584
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 29 Sept 2025 to the primary completion date, 28 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy resulting in overlapping radiation fields.
- Severe and/or active comorbidities precluding tolerance of concurrent chemoradiotherapy.
Other illness
- 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 with radiographically visible residual disease post-surgery requiring boost during the pelvic EBRT.
- History of other malignancies.
- History of allergic reaction to platinum-based chemotherapy agents.
Other
- Patients who refuse to undergo anal canal MRI.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.