Health TrialsbyHealthPanel

Quantifying Radiation Induced Vaginal Stenosis

ConditionsVaginal StrictureVaginal Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

leukocytes ≥2,500/mcL

absolute neutrophil count ≥1,500/mcL

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • UCSD Vaginal Dilator Questionnaire

    Other intervention

    14 question survey

  • EORTC Sexual Health Questionnaire

    Other intervention

    22 question survey

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Cohort 12 interventions

Trial outcomes

Primary outcomes

1

Quantify radiation induced vaginal stenosis

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

Time frame
1.5 years
2

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

Time frame
1.5 years
3

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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