Measuring vaginal narrowing after radiation treatment for cervical cancer
Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
This study is trying to see how radiation treatment for cervical cancer affects vaginal narrowing in patients, to better understand their experiences and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05002751 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify vaginal stenosis, a common side effect of radiation therapy in cervical cancer patients. It will enroll 12 subjects undergoing radiotherapy or brachytherapy and will utilize physical measurements and patient-reported outcomes to assess the severity of vaginal narrowing over time. Measurements will be taken at various follow-up intervals using a commercial dilator set, alongside validated sexual health surveys to understand patient experiences and preferences. The goal is to develop a generalizable metric for vaginal stenosis and inform the creation of a personalized treatment device.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed advanced cervical cancer who are scheduled to receive radiotherapy or brachytherapy.
Not a fit: Patients with early-stage cervical cancer or those not receiving radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment options for patients experiencing vaginal stenosis after radiation therapy.
How similar studies have performed: While there is limited research specifically quantifying vaginal stenosis post-radiation, similar studies on treatment side effects have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California
- UCSD Moores Cancer Center — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Jyoti Mayadev, MD — University of California, San Diego Moores Cancer Center
- Study coordinator: Sandi Matranga, MHA
- Email: smatranga@health.ucsd.edu
- Phone: 619-838-9003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.