Know Cancer

or
forgot password

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

Thank you

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 Hospital Denver, Colorado  80262