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

Active, not recruiting

• Conditions: Cervical Carcinoma; Vulvar Carcinoma; Malignant Pelvic Neoplasm; Vaginal Carcinoma; Anal Carcinoma; Endometrial Carcinoma; Rectal Carcinoma
• Interventions: Procedure: Pelvic Examination; Other: Survey

• Registration Number: NCT04713618
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer.

II. To examine changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.

III. To compare physical exam and patient-reported outcome trajectories over time.

OUTLINE:

Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-19
• Study Start: 2021-01-30
• Primary Completion: 2023-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supportive Care (pelvic exam, survey)	Pelvic Examination	Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.
Supportive Care (pelvic exam, survey)	Survey	Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.

Primary Outcome Measures

Name	Time	Method
Change in vulvovaginal symptoms	Baseline up to 2 year after RT	The Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS) are tools to identify vulvovaginal symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia. Items are scored 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Change in physical exam findings	Baseline up to 2 years after radiation therapy (RT)	Vaginal Health Assessment (VHA) tool; vaginal length and diameter will be reported as categorical variables (Eaton et al., 2017). Estimates will be \<2.5, 2.5, 3.0, 3.5, 4.0 or \>4 cm. Vaginal length will be estimated based on manual exam. Estimates will be \<4cm, 4-6cm, and \>6cm. We will first test bivariate correlations between physical exam outcomes and categorical sociodemographic factors using Fisher's exact test at each time point. The study team will test bivariate correlations between physical exam outcomes and continuous sociodemographic factors using ANOVA at each time point. Next, the study team will employ one-tailed Wilcoxon signed-rank test to assess the effects of radiation by comparing 1-month, 3-month, 6-month, 12-month and 24-month physical exam outcomes to baseline.
Change in sexual function	Baseline up to 2 year after RT	Female Sexual Functioning Index (FSFI) is a 19 item self -reported instrument measuring six domains of sexual functioning including arousal, orgasm, satisfaction and pain. The maximum score is 36 and a score of ≤ 26.0 indicates sexual dysfunction. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.

Secondary Outcome Measures

Name	Time	Method
Change in vaginal microbiome	Baseline up to 2 year after RT	The Lactobacillus to Prevotella ratio (LPR) will be calculated. The vaginal dryness (binary, VAS score \<=2 vs \>2) will be related to the LPR (continuous) by logistic regression. A significant relationship of LPR with vaginal dryness will be evaluated by Wald test. The LPR is correlated with abundance of macrophages by Spearman correlation. Spearman correlation is used to determine the association between LPR relative abundance and expression of a gene or composition of the immune cells. We will use linear discriminant analysis to explore a linear combination of gene expression, microbe relative abundance and immune cell composition to predict vaginal dryness. The level of inflammation in the tissue will be estimated by aggregating the expression of standard "inflammasome" genes. LPR will be correlated with the aggregated inflammation value by Spearman correlation.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States