Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy
This study is currently recruiting participants.
Verified April 2013 by University of Colorado, Denver
Sponsor:
University of Colorado, Denver
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: April 24, 2013
Last verified: April 2013
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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 2015 |
| Estimated Primary Completion Date: | December 2014 (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: | April 24, 2013 |
| 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 June 17, 2013