Hyaluronic Acid-based Gel Spacers in Cervical Cancer
This study is testing a hyaluronic acid-based gel spacer called Barrigel in women with cervical cancer who are receiving chemoradiotherapy (chemoRT), including brachytherapy. The goal is to see if placing this gel between the cervix and the rectum can reduce the amount of radiation that reaches the rectum, a nearby healthy organ. Researchers will also look at whether the gel helps deliver the correct radiation dose to the tumor. They will measure safety by tracking serious side effects and by asking participants about their bowel health and other symptoms up to three months after radiotherapy ends. To join, you must be at least 18 years old and willing to follow study procedures. The study plans to enroll 14 participants, but its current status is unclear.
- Study design
- This is a pilot feasibility study, meaning it's a small study to see if the approach is practical and safe. It will involve 14 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and symptom reporting up to three months after completing radiotherapy.
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Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shivani Sud, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placementUp to 3 months after completion of radiotherapy
The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Number of participants with Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement will be presented.
- Safety based on Patient Reported Outcome Report based on The Expanded Prostate Cancer Index Composite (EPIC) Bowel AssessmentUp to 3 months after completion of radiotherapy
Patient assessments of symptom characteristics will be surveyed based on the Patient Reported Outcome Report, based on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment. Each item in the EPIC bowel domain uses a 5-point Likert scale. The responses are numerically coded and then converted to a 0-100 scale, where higher scores = better function / less bother. No problem=1, very small problem =2, small problem=3, moderate problem=4, big problem=5
- Safety based on Patient Reported Outcome Report based on Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)Up to 3 months after completion of radiotherapy
The PRO-CTCAE survey, focused on gastrointestinal and genitourinary symptoms, will be used assessment of toxicity. The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities reported from the patient perspective. PRO-CTCAE uses 5-point Likert scales to assess the frequency, severity, and daily life interference of patient-reported symptoms, with higher scores indicating more frequent, severe, or bothersome experiences.
- Distance between uterus/cervix/proximal vagina and rectumUp to 7 weeks (at the end of radiotherapy)
The distance between the uterus, cervix, proximal vagina, and rectum will be measured using images acquired during brachytherapy.
- Gel placement procedure timeUp to 7 weeks (at the end of radiotherapy)
Time required to complete gel placement will be reported.
- Difficulty of gel placementUp to 7 weeks (at the end of radiotherapy)
Difficulty of Barrigel Procedure Insertion will be graded based on provider response to a 4-point scale survey. Higher scores represent difficult insertions. 1- Very Easy: All anatomical landmarks were easy to spot on transrectal ultrasonogram (TRUS), and Barrigel was well-visualized during injection. The tissue is separated well with Barrigel. Visible spacing between the cervix and rectum was achieved. The implant was positioned well and sculpted to the desired (symmetric) shape. 2- Easy: Most landmarks were easily seen, Barrigel was well-visualized, tissue separated reasonably well overall, although the shape may not be ideal. 3- Difficult: Some anatomy or Barrigel was difficult to visualize on TRUS, and/or the tissue didn't separate well in places with Barrigel. Spacing goals were notably not achieved, but some useful space was provided. 4- Very Difficult: The TRUS visibility was compromised, and/or the gel didn't get injected as planned due to tissue.