Quantifying Radiation-Induced Vaginal Stenosis in Cervical Cancer Patients

This observational study aims to better understand and measure vaginal stenosis (narrowing, tightening, and scarring of the vagina) that can happen after radiation treatment for cervical cancer. Up to 88% of patients treated with radiation for cervical cancer experience this condition, but it's not well understood how severe it becomes. Researchers will use specific measurements of the vagina during routine physical exams, along with two surveys: the UCSD Vaginal Dilator Questionnaire and the EORTC Sexual Health Questionnaire. The goal is to develop a way to measure the severity of vaginal stenosis and to understand patients' concerns and preferences for treatment. This information will help create a new, personalized device to treat vaginal stenosis. You may be eligible if you are a woman aged 18-99 with newly diagnosed advanced cervical cancer who will receive radiation or brachytherapy.

Study design: This is a single-arm observational study planning to enroll 12 participants. It is not a drug trial, but rather focuses on collecting data.
What's involved: You would have physical measurements of your vagina taken during routine follow-up exams after radiation treatment (after RT, 3 months, 6 months, and 12 months). You would also complete two surveys.
Compensation: Not stated in the trial record.
Follow-up: The study will collect data for up to 1.5 years after treatment.

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Quantifying Radiation Induced Vaginal Stenosis

Recruiting

Not specifiedAges 18–99Observational

University of California, San Diego

~12 participants

Updated 2025-07-09 on ClinicalTrials.gov

What's tested:UCSD Vaginal Dilator QuestionnaireEORTC Sexual Health Questionnaire

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Quantify radiation induced vaginal stenosis

Measured over 1.5 years

+2 more outcomes measured

Conditions

Vaginal Stricture

Vaginal Stenosis

Where it's being run

1 sites across 1 states

California1

Study leadership

Jyoti Mayadev, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego Moores Cancer Center

Who to contact

Sandi Matranga, MHA

[email protected]

619-838-9003

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Eligibility criteria

Inclusion

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 must have normal organ and marrow function as defined below:

Age is \> 18 years.

Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.

Ability to understand and the willingness to sign a written informed consent document.

Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:

A stable regimen of highly active anti-retroviral therapy (HAART)

No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections

A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.

Exclusion

Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.

Patients with PALN nodal metastasis above the T12/L1 interspace.

Patients who had a radical hysterectomy with positive PALNs are not eligible.

Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.

Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.

Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)

History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's

What this trial measures

Quantify radiation induced vaginal stenosis1.5 years
acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models
Acquire Patients' Treatment Concerns and Preferences1.5 years
Using a series of sexual and vaginal health questionnaires presenting an array of scaled (quantified) options we will determine patients' perceived flaws about current treatment and their preferences, and integrate them with the VS measurement results of Aim1 to guide modification and optimization of our soft balloon VS treatment system
Optimize and Validate Vaginal Stenosis Treatment System1 year
Incorporating the multimodal vaginal stenosis measurements and patient preferences acquired in Aim 1, we will use computer modelling based on known vaginal wall properties to simulate and predict the long-term outcomes of balloon-driven, graded vaginal expansion to counteract VS. Benchtop experimentation will utilize an inflatable balloon-type device and 3D printed biomimetic stenosed vaginal phantoms to test the proposed treatment effect over various time periods emulating different stages of fibrotic stenosis. To directly test our working hypothesis results acquired from modeling will be compared statistically to benchtop data.

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