A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy

NCT07175584 | Not Yet Recruiting DMC

• 1 other identifier: SHGH_IIT2025-070
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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, 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

Hemorrhoidal Disease; Cervical Cancer Radiation Complications

Keywords

cervical cancer; hemorrhoidal disease; pelvic radiation therapy

Outcome Measures

Primary Outcomes (1)

• The incidence of radiation-induced hemorrhoid-related symptoms

  From the initiation of pelvic radiation therapy (including BT) until 4 weeks after its completion.

Study Arms (2)

Anal Canal-Sparing Arm

EXPERIMENTAL

Participants will receive pelvic radiation therapy using anal canal-sparing techniques. There will be 150 participants enrolled.

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.

Interventions

anal canal-sparing techniques RADIATION

To contour anal canal and rectum separately and deliver different doses as two single OARs in pelvic radiation therapy planning.

Anal Canal-Sparing Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• RenJi Hospital: collaborator
• Suzhou Municipal Hospital: collaborator
• Changzhou Cancer Hospital of Soochow University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yong Liu

CONTACT

+86 17301642976; drliuyrt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)