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New radiation method aims to spare anal canal, cut hemorrhoid misery in cervical cancer patients

NCT ID NCT07175584

Symptom relief Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This trial tests whether protecting the anal canal during pelvic radiation can reduce hemorrhoid-related symptoms like pain, bleeding, and discomfort in cervical cancer patients. 300 women who had a hysterectomy and need radiation will be randomly assigned to standard radiation or a technique that delivers a lower dose to the anal canal. The goal is to improve quality of life without affecting cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
anal canal-sparing radiation technique
What this could lead to
If it works, this could reduce painful hemorrhoid symptoms during pelvic radiation for cervical cancer patients, improving their quality of life.
What could go wrong
This is an early-stage trial (not yet recruiting) and focuses on symptom reduction, not curing cancer. The benefit may be small or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical carcinoma hemorrhoid Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer radiation complications Hemorrhoidal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.