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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Malignancies; Stenosis of Vagina

Study type: Observational

Funder types: Other

Identifiers

NCT01404728

11-0454.cc

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

8 participants in 1 patient group

Pelvic Malignancies

Description:

Women with Vaginal Stenosis