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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-08

Study Completion Date

2017-03-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Malignancies Stenosis of Vagina

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pelvic Malignancies

Women with Vaginal Stenosis

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No