Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy

This study is currently recruiting participants.
Verified February 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
University of Colorado Hospital
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01404728
First received: July 26, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.


Condition
Malignancies
Stenosis of Vagina

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Observation of a change in vaginal length from baseline measurement [ Time Frame: Outcomes will be measured at baseline, for patients in the radiation group this will be prior to any ] [ Designated as safety issue: No ]
    Based on prior studies we expect that women who receive pelvic radiation therapy and are noncompliant with dilator use will have a ≥1cm decrease in vaginal length. Observation of change in sexual function/satisfaction or increase in sexual discomfort compared to prior to treatment as measured by the Sexual Adjustment Questionnaire (SAQ)


Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pelvic Malignancies
Women with Vaginal Stenosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women being treated for pelvic malignancies in the primary care clinic.

Criteria

Inclusion Criteria:

  • Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma.
  • Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies.
  • May have early-stage or locally advanced (node positive) disease.
  • Male partners of the female subjects are also consented for this study.

Exclusion Criteria:

  • Subject may not have evidence of metastatic disease.
  • Prior pelvic radiation therapy
  • Prior hysterectomy (not for current diagnosis)
  • Diagnosis of prior malignancy, except non-melanoma skin cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404728

Contacts
Contact: Christine Fisher, MD 720-848-0696 Christine.Fisher@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennie Areson    720-848-0696    Jennie.Areson@ucdenver.edu   
Sub-Investigator: Emma C. Fields, MD         
Principal Investigator: Christine Fisher, MD         
Sponsors and Collaborators
University of Colorado, Denver
University of Colorado Hospital
Investigators
Principal Investigator: Christine Fisher, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01404728     History of Changes
Other Study ID Numbers: 11-0454.cc
Study First Received: July 26, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Vaginal length
Sexual dysfunction

Additional relevant MeSH terms:
Neoplasms
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014