Hyaluronic acid gel spacer to protect nearby organs during cervical cancer radiation

Feasibility Study of Novel Applications of Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

This pilot tests a hyaluronic acid gel spacer (Barrigel) to see if it helps people with cervical cancer receiving chemoradiotherapy and brachytherapy by creating space between the tumor and nearby organs.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: UNC Lineberger Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT07292818 on ClinicalTrials.gov

What this trial studies

This is a phase 1 pilot at UNC testing whether a hyaluronic acid-based gel (Barrigel) can be placed to create space between the cervix and surrounding pelvic organs before chemoradiotherapy that includes brachytherapy. The primary goal is to determine feasibility of gel placement and integration into standard treatment workflows. Secondary aims include measuring whether the spacer reduces radiation dose to organs at risk (rectum, bladder, other pelvic structures) and whether it improves delivery of the prescribed tumor dose. Eligible adults planned for chemoradiotherapy with brachytherapy are enrolled, with exclusions for rectal invasion, inflammatory bowel disease, pregnancy, active infection, or known allergy to hyaluronic acid products.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed cervical cancer who are planned for chemoradiotherapy including brachytherapy, with ECOG 0–2 (or KPS 50–100) and no known rectal invasion, are ideal candidates.

Not a fit: Patients with known rectal invasion, active inflammatory bowel disease, pregnancy, active infection, or a hyaluronic acid allergy are unlikely to benefit and are excluded from participation.

Why it matters

Potential benefit: If successful, the gel spacer could lower radiation exposure to the rectum and bladder and reduce treatment-related side effects while allowing better tumor dose delivery.

How similar studies have performed: Hyaluronic acid gel spacers have been widely adopted in prostate cancer and shown to reduce rectal dose, but their use in gynecologic cancers is less established and remains investigational.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Active infection requiring systemic therapy.
* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study).
* Known allergy to hyaluronic acid-based products.
* Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

Where this trial is running

Chapel Hill, North Carolina

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Shivani Sud, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Melissa Knutsen

Conditions Cervix Cancer; radiotherapy; brachytherapy; gel spacer