Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement [Time frame: Up to 3 months after completion of radiotherapy]
• Safety based on Patient Reported Outcome Report based on The Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment [Time frame: Up to 3 months after completion of radiotherapy]
• Safety based on Patient Reported Outcome Report based on Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time frame: Up to 3 months after completion of radiotherapy]
• Distance between uterus/cervix/proximal vagina and rectum [Time frame: Up to 7 weeks (at the end of radiotherapy)]
• Gel placement procedure time [Time frame: Up to 7 weeks (at the end of radiotherapy)]
• Difficulty of gel placement [Time frame: Up to 7 weeks (at the end of radiotherapy)]

Secondary outcome measures (1)

• Implant geometry [Time frame: Up to 7 weeks (at the end of radiotherapy)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07292818 · LCCC2310

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗