Active — Not RecruitingNot Applicable

Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy

United States72 participantsStarted 2021-01-30

Plain-language summary

This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy * Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166 * Any prior gynecologic surgery is permitted * Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted Exclusion Criteria: * Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded * Patients who have received prior pelvic radiation

What they're measuring

Change in physical exam findings

Timeframe: Baseline up to 2 years after radiation therapy (RT)

Change in vulvovaginal symptoms

Timeframe: Baseline up to 2 year after RT

Change in sexual function

Timeframe: Baseline up to 2 year after RT

Trial details

NCT IDNCT04713618

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-01