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

Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404728
• Other study ID #: 11-0454.cc
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: April 27, 2017
• Start date: January 8, 2013
• Est. completion date: March 1, 2017

Study information

• Verified date: April 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2017
• Est. primary completion date: January 22, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Malignancies
• Neoplasms
• Stenosis of Vagina

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)	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.	Up to 24 Months
Primary	Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)	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.	Up to 24 Months