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Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignancies, Stenosis of Vagina

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Trial Information

Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Observation of a change in vaginal length from baseline measurement

Outcome Description:

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)

Outcome Time Frame:

Outcomes will be measured at baseline, for patients in the radiation group this will be prior to any

Safety Issue:

No

Principal Investigator

Christine Fisher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

11-0454.cc

NCT ID:

NCT01404728

Start Date:

June 2011

Completion Date:

December 2015

Related Keywords:

  • Malignancies
  • Stenosis of Vagina
  • Vaginal length
  • Sexual dysfunction
  • Neoplasms
  • Constriction, Pathologic

Name

Location

University of Colorado HospitalDenver, Colorado  80262