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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT01404728

Collaborator

(none)

Enrollment

Location

49.7

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignancies Stenosis of Vagina

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.

Study Design

Study Type:

Observational

Actual Enrollment :

8 participants

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

Actual Study Start Date :

Jan 8, 2013

Actual Primary Completion Date :

Jan 22, 2013

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Pelvic Malignancies Women with Vaginal Stenosis

Outcome Measures

Primary Outcome Measures

Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator) [Up to 24 Months]
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) [Up to 24 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Christine Fisher, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01404728

Other Study ID Numbers:

11-0454.cc

First Posted:

Jul 28, 2011

Last Update Posted:

May 1, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University of Colorado, Denver

Vaginal length

Sexual dysfunction

Additional relevant MeSH terms:

Neoplasms

Constriction, Pathologic

Study Results

No Results Posted as of May 1, 2017