Evaluation of Sexual Toxicities in Women After Pelvic Radiotherapy
Anal Cancer
Cervical Cancer
Colon/Rectal Cancer
Gynecologic Cancers
Solid Tumor
Uterine Cancer
18 Years and older, Female
20-2369 (primary)
NCI-2022-05850
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.
Eligibility
- Patients with female sexual organs ages 18 and older
- Patient who have been sexually active in the 12 months prior to cancer diagnosis.
*As defined by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) ('Examples of sexual activity are masturbation, oral sex, and sexual intercourse')
- Patients must be able to provide consent and be willing to participate
- Patients must have primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer planned to receive pelvic radiotherapy.
* Note: healthy and/or non-irradiated controls in each disease type (10-15 per group), when needed, will be recruited for pilot and/or validation studies. Healthy controls must have been sexually active in the 12 months prior to enrollment
- Patients must have an Eastern Cooperative Oncology Group performance status =< 2
Treatment Sites in Georgia
**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...
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