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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brachytherapy with hyaluronic acid-based gel spacer 		Patients with cervical cancer who are scheduled to undergo definitive chemoradiotherapy, including brachytherapy, with the use of hyaluronic acid-based gel spacer to increase the distance between the cervix and the anterior rectal wall.
  • Device: Barrigel gel spacer
    Barrigel (Hyaluronic acid- based gel spacer) will be used to increase the distance between the cervix and the anterior rectal wall, with the intent to decrease the radiation dose delivered to the rectum.
    Other names:
    • Hyaluronic acid- based rectal spacer

Recruiting Locations

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Melissa Knutsen
919-918-5924
Melissa_Knutsen@med.unc.edu

More Details

Status
Recruiting
Sponsor
UNC Lineberger Comprehensive Cancer Center

Study Contact

Melissa Knutsen
919-966-4432
Melissa_Knutsen@med.unc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.