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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01404728
First received: July 26, 2011
Last updated: June 10, 2016
Last verified: June 2016
  Purpose
This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

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

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

Primary Outcome Measures:
  • Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator) [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    Observation of change in vaginal length will be measured at baseline (which for the patients in the radiation group will be prior to any pelvic radiation therapy and for patients in the surgery group this will be at the first post-operative visit), as well as in follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.

  • Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ) [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    The baseline SAQ will be administered prior to radiation therapy for the pelvic malignancy group and it will be administered at the post-operative visit for the surgery only group, and the post-treatment SAQ version will be given at the follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements.


Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pelvic Malignancies
Women with Vaginal Stenosis

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Monica Robischon, RN    720-848-0661    Monica.Robischon@ucdenver.edu   
Sub-Investigator: Emma C. Fields, MD         
Principal Investigator: Christine Fisher, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Christine Fisher, MD University of Colorado, Denver
  More Information

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: June 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 27, 2016