Status:
COMPLETED
Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy
Lead Sponsor:
University of Colorado, Denver
Conditions:
Malignancies
Stenosis of Vagina
Eligibility:
All Genders
18+ years
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.
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01404728
Start Date
January 8 2013
End Date
March 1 2017
Last Update
May 1 2017
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045