RECRUITING

Quantifying Radiation Induced Vaginal Stenosis

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Conditions

Vaginal StrictureVaginal StenosisRadiotherapy Side EffectBrachytherapy Side Effect

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device

Quick Facts

Study Start:2022-10-06
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05002751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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.
  2. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).
  3. * Patients must have normal organ and marrow function as defined below:
  4. 1. leukocytes ≥2,500/mcL
  5. 2. absolute neutrophil count ≥1,500/mcL
  6. 3. platelets ≥100,000/mcL
  7. 4. hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
  8. 5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
  9. 6. AST(SGOT)/ALT(SGPT) ≤3 × ULN
  10. 7. alkaline phosphatase ≤2.5 × ULN
  11. 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.)
  12. * Age is \> 18 years.
  13. * Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.
  14. * Ability to understand and the willingness to sign a written informed consent document.
  15. * Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:
  16. * A stable regimen of highly active anti-retroviral therapy (HAART)
  17. * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  18. * A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.
  1. * 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.
  2. * Patients with PALN nodal metastasis above the T12/L1 interspace.
  3. * Patients who had a radical hysterectomy with positive PALNs are not eligible.
  4. * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  5. * Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
  6. * 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)
  7. * 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

Contacts and Locations

Study Contact

Sandi Matranga, MHA
CONTACT
619-838-9003
smatranga@health.ucsd.edu
Jyoti Mayadev, MD
CONTACT
jmayadev@health.ucsd.edu

Principal Investigator

Jyoti Mayadev, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego Moores Cancer Center

Study Locations (Sites)

UCSD Moores Cancer Center
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Jyoti Mayadev, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego Moores Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-06
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-10-06
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Vaginal Stricture
  • Vaginal Stenosis