Hemorrhoidal DiseaseACS-RTNCT07175584
A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy
A study testing anal canal-sparing techniques in people with Hemorrhoidal Disease and Cervical Cancer Radiation Complications, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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, local burning, bleeding, perianal pain, and other perianal discomforts. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Hemorrhoidal Disease, Cervical Cancer Radiation Complications
- What is being tested?
- anal canal-sparing techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Ge Yan, +86 13636310079, geyan@shsmu.edu.cn
Yong Liu
About this study
Official title: Anal Canal-Sparing Technique During Postoperative Pelvic Radiation Therapy for Cervical Cancer Patients to Reduce Hemorrhoids-related Symptoms: A Multicenter Randomized Clinical Trial
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:
Read more
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.
Read the 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 particularly important, which plays a crucial role for patients either after surgery or for those ineligible for surgery. In intensity-modulated radiation therapy (IMRT) era, 90-95% of patients with pelvic malignancies, including gynecological tumors, still develop varying degrees of radiation-induced intestinal injury. Radiation-induced rectal injury (RRI) is still one of the most common complications of radiation to the pelvis, but which is also the most difficult to treat.
However, whether from the symptoms or the pelvic radiation therapy plans, current studies on RRI generally combine the rectum and anal canal. Therefore, the so-called "Radiation-induced rectal injury" is not purely "rectal injury," but includes "radiation-induced rectal and anal canal injury." In addition, the radiation of perianal muscles can also lead to symptoms related to the rectum during pelvic radiation therapy. According to current contouring guidelines, whether for gynecologic tumors or other pelvic malignancies, the anal canal is regarded together with the rectum as the same organ at risk (OAR) when formulating pelvic EBRT plans, and a unified dose constraint standard is applied. The anal canal and its surrounding muscles are not assessed separately.
The tolerance dose of the rectum is generally considered to be around 50 Gy, however, anal canal-related symptoms may occur at lower doses, particularly in patients with a history of hemorrhoids. During the early phase of radiotherapy, hemorrhoids-associated symptoms such as perianal pain, hemorrhoidal prolapse, rectal bleeding, and perianal skin breakdown may occur. These symptoms are more likely attributable to the aggravation of pre-existing hemorrhoids rather than radiation-induced rectal injury. Hemorrhoidal disease (HD) is one of the most common gastrointestinal disorder managed in outpatient clinics. Although it is not a life-threatening condition, it can persistently and severely impact quality of life and increase the healthcare burden on society.
Anal canal toxicity should not be a neglected side-effect of pelvic radiation therapy, and greater attention need to be paid to the occurrence of acute hemorrhoid-related symptoms, particularly for cervical cancer patients with hemorrhoids. The investigators tried to develop anal canal-sparing technique to reduce the irradiated dose to anal canal for cervical cancer patients with hemorrhoids who needed postoperative pelvic radiation therapy.
Minimizing acute toxic effects is of considerable importance to improve quality of life because it has been correlated with late toxic effects in patients with pelvic radiation therapy. Herein, the investigators design a multicenter, double-blind randomized controlled trial in which cervical cancer patients with hemorrhoids were randomly assigned to receive anal canal-sparing or standard postoperative pelvic radiation therapy, in either combined with brachytherapy or not.
The primary objectives are to compare the incidence of hemorrhoidal symptom and differences in quality of life (QoL) scores during radiotherapy between the two arms. Concurrently, the study will explore the practical implementation methodology of the anal canal-sparing technique.
- Being tested
- anal canal-sparing techniques
- Keywords
- cervical cancer, hemorrhoidal disease, pelvic radiation therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anal canal-sparing techniquesRadiation
To contour anal canal and rectum separately and deliver different doses as two single OARs in pelvic radiation therapy planning.
| Study group | Role | What they receive |
|---|---|---|
| Anal Canal-Sparing Arm | Experimental | Participants will receive pelvic radiation therapy using anal canal-sparing techniques. There will be 150 participants enrolled. Receives: Radiation: anal canal-sparing techniques |
| Conventional Radiation therapy Arm | No intervention | Participants will receive pelvic radiation therapy using standard techniques. There will be 150 participants enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of radiation-induced hemorrhoid-related symptoms
Measured: From the initiation of pelvic radiation therapy (including BT) until 4 weeks after its completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start29 Sep 2025 (estimated)
- Primary completion28 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoidal DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Suzhou Municipal Hospital, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Yong Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175584
- Sponsor's protocol ID
- SHGH_IIT2025-070
- Acronym
- ACS-RT
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Canal-Sparing Technique During Postoperative Pelvic Radiation Therapy for Cervical Cancer Patients to Reduce Hemorrhoids-related Symptoms: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07175584
- Acronym / sponsor ID
- ACS-RT / SHGH_IIT2025-070
- Keywords
- cervical cancer, hemorrhoidal disease, pelvic radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital, Suzhou Municipal Hospital, Changzhou Cancer Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University
- Study start
- 29 Sep 2025 (estimated)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 particularly important, which plays a crucial role for patients either after surgery or for those ineligible for surgery. In intensity-modulated radiation therapy (IMRT) era, 90-95% of patients with pelvic malignancies, including gynecological tumors, still develop varying degrees of radiation-induced intestinal injury. Radiation-induced rectal injury (RRI) is still one of the most common complications of radiation to the pelvis, but which is also the most difficult to treat.
However, whether from the symptoms or the pelvic radiation therapy plans, current studies on RRI generally combine the rectum and anal canal. Therefore, the so-called "Radiation-induced rectal injury" is not purely "rectal injury," but includes "radiation-induced rectal and anal canal injury." In addition, the radiation of perianal muscles can also lead to symptoms related to the rectum during pelvic radiation therapy. According to current contouring guidelines, whether for gynecologic tumors or other pelvic malignancies, the anal canal is regarded together with the rectum as the same organ at risk (OAR) when formulating pelvic EBRT plans, and a unified dose constraint standard is applied. The anal canal and its surrounding muscles are not assessed separately.
The tolerance dose of the rectum is generally considered to be around 50 Gy, however, anal canal-related symptoms may occur at lower doses, particularly in patients with a history of hemorrhoids. During the early phase of radiotherapy, hemorrhoids-associated symptoms such as perianal pain, hemorrhoidal prolapse, rectal bleeding, and perianal skin breakdown may occur. These symptoms are more likely attributable to the aggravation of pre-existing hemorrhoids rather than radiation-induced rectal injury. Hemorrhoidal disease (HD) is one of the most common gastrointestinal disorder managed in outpatient clinics. Although it is not a life-threatening condition, it can persistently and severely impact quality of life and increase the healthcare burden on society.
Anal canal toxicity should not be a neglected side-effect of pelvic radiation therapy, and greater attention need to be paid to the occurrence of acute hemorrhoid-related symptoms, particularly for cervical cancer patients with hemorrhoids. The investigators tried to develop anal canal-sparing technique to reduce the irradiated dose to anal canal for cervical cancer patients with hemorrhoids who needed postoperative pelvic radiation therapy.
Minimizing acute toxic effects is of considerable importance to improve quality of life because it has been correlated with late toxic effects in patients with pelvic radiation therapy. Herein, the investigators design a multicenter, double-blind randomized controlled trial in which cervical cancer patients with hemorrhoids were randomly assigned to receive anal canal-sparing or standard postoperative pelvic radiation therapy, in either combined with brachytherapy or not.
The primary objectives are to compare the incidence of hemorrhoidal symptom and differences in quality of life (QoL) scores during radiotherapy between the two arms. Concurrently, the study will explore the practical implementation methodology of the anal canal-sparing technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anal Canal-Sparing Arm | Experimental | Radiation: anal canal-sparing techniquesParticipants will receive pelvic radiation therapy using anal canal-sparing techniques. There will be 150 participants enrolled. |
| Conventional Radiation therapy Arm | No intervention | –Participants will receive pelvic radiation therapy using standard techniques. There will be 150 participants enrolled. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anal canal-sparing techniquesTo contour anal canal and rectum separately and deliver different doses as two single OARs in pelvic radiation therapy planning. | Radiation | Anal Canal-Sparing Arm |
Primary outcome
The incidence of radiation-induced hemorrhoid-related symptoms
Time frame: From the initiation of pelvic radiation therapy (including BT) until 4 weeks after its completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anal canal-sparing techniques in people with Hemorrhoidal Disease and Cervical Cancer Radiation Complications, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Liu (+86 17301642976, drliuyrt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of radiation-induced hemorrhoid-related symptoms (time frame: From the initiation of pelvic radiation therapy (including BT) until 4 weeks after its completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.