Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
University of California, San Diego
Summary
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
Description
This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis. The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.
Eligibility
- Age range
- 18–99 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II). * Patients mu…
Interventions
- OtherUCSD Vaginal Dilator Questionnaire
14 question survey
- OtherEORTC Sexual Health Questionnaire
22 question survey
Location
- UCSD Moores Cancer CenterLa Jolla, California