Hyaluronic Acid Gel Spacer for Cervical Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a gel spacer made from hyaluronic acid to determine its effectiveness for cervical cancer patients undergoing radiation therapy. The gel, called Barrigel, is placed between the cervix and nearby organs like the rectum and bladder to protect them from radiation and potentially enhance treatment effectiveness. The main goal is to assess the practicality of using this gel and its ability to reduce radiation exposure to healthy organs. This trial targets individuals diagnosed with cervical cancer who are scheduled to receive chemoradiotherapy and brachytherapy (a type of internal radiation). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this gel spacer is safe for use in cervical cancer treatment?
Research shows that hyaluronic acid gel spacers, such as Barrigel, are generally well-tolerated. In previous studies with prostate cancer patients, these gel spacers successfully reduced radiation exposure to healthy tissues, protecting sensitive organs like the rectum and bladder during radiation therapy.
Although Barrigel is new to cervical cancer treatment, it has not raised major safety concerns in similar applications. A study on its use in cervical cancer found that serious side effects were rare, with most patients not experiencing life-threatening issues from the gel.
Overall, using a gel spacer like Barrigel is considered safe based on its use in other cancers. It aims to improve treatment while minimizing harm to healthy organs.12345Why do researchers think this study treatment might be promising?
The treatment using a hyaluronic acid-based gel spacer is unique because it aims to increase the distance between the cervix and the anterior rectal wall during brachytherapy for cervical cancer. Unlike standard treatments like surgery, radiation, and chemotherapy, this gel spacer can potentially reduce radiation exposure to surrounding healthy tissues, minimizing side effects. Researchers are excited about this innovative approach as it could lead to more targeted treatment, enhancing the safety and comfort of patients undergoing chemoradiotherapy.
What evidence suggests that this gel spacer is effective for cervical cancer?
In this trial, participants will receive brachytherapy with a hyaluronic acid-based gel spacer, such as Barrigel, to increase the distance between the cervix and the anterior rectal wall. Research has shown that hyaluronic acid gel spacers reduce radiation exposure to nearby healthy organs. Past studies found that these spacers improve radiation delivery to tumors by creating a gap between the tumor and sensitive organs. This method has been especially successful in treating prostate cancer, where it protects the rectum from radiation. Early results suggest that using gel spacers in cervical cancer can also lower the risk of radiation affecting the bladder and rectum, potentially leading to better tumor control and fewer treatment side effects.14678
Who Is on the Research Team?
Shivani Sud, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with cervical cancer who are about to undergo chemoradiotherapy, including brachytherapy. Participants must be suitable for the insertion of a gel spacer and willing to follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Gel Spacer Placement
Participants undergo the procedure to insert hyaluronic acid-based gel spacers to increase the distance between the cervix and the anterior rectal wall
Chemoradiotherapy
Participants receive chemoradiotherapy, including brachytherapy, as part of standard care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and symptom characteristics
What Are the Treatments Tested in This Trial?
Interventions
- Barrigel
Trial Overview
The study tests if using Barrigel, a hyaluronic acid-based gel spacer, can protect nearby healthy organs from radiation during treatment. It's inserted before therapy to see if it reduces side effects and improves tumor targeting.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Teleflex
Industry Sponsor
Citations
Hyaluronic Acid-based Gel Spacers in Gynecologic ...
This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer ...
A new hyaluronate gel spacer and injection technique for ...
Spacers separating the tumor from adjacent organs help improve irradiation dose parameters. We introduce a new hyaluronate gel spacer with ...
Effect of Hyaluronate Acid Injection on Dose-Volume ...
This study aims to report the effect of HGI on dose-volume parameters, especially on CTV, for patients with cervical cancer.
Spacer in Gynaecological MRI-guided brachytherapy
Barrigel is used as a rectal spacer in prostate cancer radiation therapy but has had limited use in gynaecological cancers. Hyaluronic acid gel ...
Safe and Effective | Barrigel for Healthcare Providers
Barrigel is also the only rectal spacer proven superior in the reduction of grade 1+ GI toxicity at 3 and 6 months, compared to control.1,2 ...
Hyaluronic Acid-based Gel Spacers in Gynecologic ...
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Number of participants with Grade 3 or higher adverse events ...
A phase I clinical trial evaluating the application of ...
This study represents a prospective phase I clinical research to verify the effectiveness and reliability of hydrogel application in Chinese cervical cancer ...
Role of the gel spacer in safely delivering whole pelvic ...
The use of gel spacer can enable ESTRO/ABS-recommended dose constraints even without using CS in EBRT, with favorable outcomes and low adverse event rates.
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