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

Completed

Conditions studied: Malignancies, Stenosis of Vagina

In brief

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

Key facts

Study ID

NCT01404728

Run by

University of Colorado, Denver

People needed

8

Starts

2013-01-08

Expected to finish

2017-03-01

Last updated by the study team

2017-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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