Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05002751

Conditions

Vaginal Stricture

Vaginal Stenosis

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

UCSD Vaginal Dilator Questionnaire

EORTC Sexual Health Questionnaire

Study Details

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

Study ID

NCT05002751

Start date

Oct 6, 2022

Status verified date

Jul, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Apr 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 must have normal organ and marrow function as defined below:

1. leukocytes ≥2,500/mcL
2. absolute neutrophil count ≥1,500/mcL
3. platelets ≥100,000/mcL
4. hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
6. AST(SGOT)/ALT(SGPT) ≤3 × ULN
7. alkaline phosphatase ≤2.5 × ULN
8. 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:
  • 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 Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

UCSD Vaginal Dilator Questionnaire

14 question survey

EORTC Sexual Health Questionnaire

22 question survey

Primary outcome measure

  • Quantify radiation induced vaginal stenosis [ Time Frame: 1.5 years ]
  • Acquire Patients' Treatment Concerns and Preferences [ Time Frame: 1.5 years ]
  • Optimize and Validate Vaginal Stenosis Treatment System [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Keywords

  • Vaginal Stenosis
  • Vaginal Stricture
  • Radiotherapy Side Effect
  • Brachytherapy Side Effect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-07-09.