Evaluation of Sexual Toxicities in Women After Pelvic Radiotherapy

Active:	Yes
Cancer Type:	Anal Cancer Cervical Cancer Colon/Rectal Cancer Gynecologic Cancers Solid Tumor Uterine Cancer	NCT ID:	NCT05394428
Trial Phases:		Protocol IDs:	20-2369 (primary) NCI-2022-05850
Eligibility:	18 Years and older, Female	Study Type:	Other
Study Sponsor:	Icahn School of Medicine at Mount Sinai
NCI Full Details:	http://clinicaltrials.gov/show/NCT05394428

Summary

This study evaluates the impact of pelvic radiotherapy (RT) on sexual function in cancer patients with female sexual organs. About 1 million female patients in the United States are diagnosed with a pelvic cancer and about half of those receive RT during their course of treatment. Radiation therapy (radiotherapy) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Normal tissues that are near the tumor cells can be damaged when exposed to radiation during treatment. Currently, there is little knowledge on the effects RT has on female sexual organs and the resulting impact on sexual function and quality of life (QOL). This study may help researchers understand how radiotherapy impacts sexual function and may help doctors develop ways to prevent, or reduce sexual side effects and improve QOL in women after RT.

Objectives

PRIMARY OBJECTIVES:
I. Establish a clinically-annotated sexual quality of life and biomarker cohort and biorepository.
II. Establish an anatomic domain-based classification of long-term radiation-related sexual dysfunction, measured with clinician- and patient-reported outcomes in a multi-center, prospective, longitudinal cohort of female pelvic radiotherapy patients.
III. Define and/or validate novel dosimetric predictors of sexual dysfunction in each anatomic domain.
IV. Identify quantitative imaging biomarker indices of radiation damage to specific sexual organs.
V. Identify microbial biomarker indices of radiation damage to specific sexual organs.

SECONDARY OBJECTIVE:
I. To create an integrated, clinically-annotated biorepository to enable future analysis of predictors of radiation toxicity, tumor formation, or response to therapy.

OUTLINE: This is an observational study.

QOL COHORT: Patients complete questionnaires and undergo specimen collections and electronic medical record reviews throughout study.

IMAGING COHORT (substudy): Some patients on the main QOL cohort also undergo ultrasound imaging (US) and standard of care magnetic resonance imaging (MRI) with additional imaging.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.