Quantifying Radiation Induced Vaginal Stenosis

NCT05002751 | Recruiting

• 2 other identifiers: QRIVS-001PAR 20-292
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Stricture; Vaginal Stenosis

Keywords

Vaginal Stenosis; Vaginal Stricture; Radiotherapy Side Effect; Brachytherapy Side Effect

Outcome Measures

Primary Outcomes (3)

• Quantify radiation induced vaginal stenosis

  acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models

  1.5 years

• Acquire Patients' Treatment Concerns and Preferences

  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

  1.5 years

• Optimize and Validate Vaginal Stenosis Treatment System

  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.

  1 year

Study Arms (1)

Cohort 1

1\. 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.

Other: UCSD Vaginal Dilator Questionnaire; Other: EORTC Sexual Health Questionnaire

Interventions

UCSD Vaginal Dilator Questionnaire OTHER

14 question survey

Cohort 1

EORTC Sexual Health Questionnaire OTHER

22 question survey

Cohort 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects over 18 years old, scheduled to receive radiotherapy and/or brachytherapy for the treatment of gynecological cancers.

You may qualify if:

• 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:
• leukocytes ≥2,500/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets ≥100,000/mcL
• hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
• total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤3 × ULN
• alkaline phosphatase ≤2.5 × ULN
• creatinine \<1.5 mg/dL INR and aPTT ≤1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)
• 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:

You may not qualify if:

• 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)
• a. transcription mediated amplification (TMA) or branched DNA testing.
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jyoti Mayadev, MD

  University of California, San Diego Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandi Matranga, MHA

CONTACT

619-838-9003; smatranga@health.ucsd.edu

Jyoti Mayadev, MD

CONTACT

jmayadev@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: October 6, 2022
• Primary Completion: April 5, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)