Quantifying Radiation Induced Vaginal 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
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 design
Treatments tested in this trial
- UCSD Vaginal Dilator Questionnaire
- EORTC Sexual Health Questionnaire
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Diego
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov