Testing a Gel Spacer to Protect Organs During Cervical Cancer Radiation
Tests a hyaluronic acid gel spacer to shield nearby organs during radiation for cervical cancer.
Plain-language title generated from the registry record
Registry title: Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
Key facts
- Where
- Chapel Hill, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel HillChapel Hill, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UNC Lineberger Comprehensive Cancer Center
- Trial code
- NCT07292818
- Record updated
- 1 October 2026
- Original description
This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer undergoing chemoradiotherapy (chemoRT), including brachytherapy, as part of standard care.Read full original descriptionShow less
Feasibility Study of Novel Applications of Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer undergoing chemoradiotherapy (chemoRT), including brachytherapy, as part of standard care.
The primary goal is to assess feasibility. Other goals include determining whether gel placement can reduce radiation dose to nearby healthy organs (organs at risk, OAR) and improve delivery of the prescribed radiation dose to the tumor.
In cervical cancer, the radiation dose to the tumor is often limited by the risk of exposing nearby sensitive organs, such as the rectum, bladder, and other pelvic structures. Vaginal packing techniques and specialized devices are used to protect these organs and ensure effective treatment. Gel spacers are inserted before radiation therapy to create space between the rectum and the cervix, reducing radiation exposure to healthy tissue. Already widely used in prostate cancer treatment in the U.S., gel spacers may also help improve tumor control and reduce treatment-related toxicity in cervical cancer.
Inclusion: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information; Subject is willing and able to comply with study procedures based on the judgment of the investigator; Age ≥ 18 years at time of consent; Eastern Cooperative Oncology Group Performance Status of 0-2 or Karnofsky Performance Scale score of 50-100; Histological or cytological evidence of cervical cancer. Only patients with cervical cancer who are planned for chemoradiotherapy with brachytherapy, except for individuals with known rectal invasion.
Exclusion: Active infection requiring systemic therapy; Known allergy to hyaluronic acid-based products; Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis; Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study).