Actively Recruiting
Quantifying Radiation Induced Vaginal Stenosis
Led by University of California, San Diego · Updated on 2025-07-09
12
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Quantifying Radiation Induced Vaginal Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed advanced cervical cancer of specified clinical stages confirmed by biopsy or imaging
- ECOG performance status 2 or better (Karnofsky 60% or higher)
- Normal organ and marrow function with specified blood count and liver/kidney values
- Age over 18 years
- No known allergy to cisplatin or similar compounds
- Ability to understand and sign informed consent
- HIV-positive patients allowed if on stable anti-retroviral therapy, no need for antibiotics/antifungals for opportunistic infections, CD4 count above 250, and undetectable viral load
You will not qualify if you...
- Prior radiation therapy to pelvis, abdominal cavity, PALN, or prior therapy for the malignancy
- PALN nodal metastasis above T12/L1 interspace
- History of radical hysterectomy with positive PALNs
- Prior bone marrow or solid organ transplantation
- Systemic anticancer therapy within 3 years prior to study
- Synchronous primary malignancy except specific exceptions
- History or risk of autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, and others
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
S
Sandi Matranga, MHA
CONTACT
J
Jyoti Mayadev, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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