Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.

Study Overview

• Status: Completed
• Conditions: Cancer; Childhood Cancer
• Intervention / Treatment: Diagnostic test: Uroflow testing; Diagnostic test: Bladder Scan; Other: Dysfunctional Voiding Scoring System Survey; Diagnostic test: DEXA Scan of pelvis and sacral spine; Diagnostic test: Urine tests for specific biomarkers

Detailed Description

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80217
      • Colorado Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cohort 1: Childhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure.

Cohort 2: Childhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex.

Description

Inclusion Criteria:

• Patients of any age who were treated were diagnosed in 2007 or later and received chemotherapy for solid tumor malignancy, with completion of therapy (whether chemotherapy or radiation) at least one year prior to study enrollment.

Exclusion Criteria:

• Patients with known dysfunctional voiding prior to cancer treatment.
• Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who received EBRT to the pelvis.; Childhood cancer survivors who were treated with chemotherapy and radiation therapy to the pelvis, with or without surgical intervention. This group will consist of both primary pelvic sarcomas as well as patients who received whole abdominal radiation that included bladder exposure.	Diagnostic test: Uroflow testing; Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.; Diagnostic test: Bladder Scan; Bladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder.; Other: Dysfunctional Voiding Scoring System Survey; The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.; Diagnostic test: DEXA Scan of pelvis and sacral spine; DEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine.; Diagnostic test: Urine tests for specific biomarkers; Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).
Control cohort.; Childhood cancer survivors who have been treated for a sarcoma who did not receive pelvic radiation, and were treated with chemotherapy, with or without surgical intervention or radiation therapy (outside of the pelvis). These patients will be matched as closely as possible to Group 1 to match chemotherapy regimens, and sex.	Diagnostic test: Uroflow testing; Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.; Diagnostic test: Bladder Scan; Bladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder.; Other: Dysfunctional Voiding Scoring System Survey; The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.; Diagnostic test: DEXA Scan of pelvis and sacral spine; DEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine.; Diagnostic test: Urine tests for specific biomarkers; Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uroflow and Bladder Scan Results	aggregate measured by voiding time (seconds, s), total voided volume (mL), average uroflow rate (mL/s), maximum uroflow rate (mL/s), uroflow pattern or curve (bell-shaped, tower-shaped, staccato, interrupted or plateau), and post void residual (mL)	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DVSS Scores	2. Total DVSS survey scores to determine patient-reported urinary symptom. Gender-specific DVSS total score thresholds: males ≥9, females ≥6. Minimum DVSS score is 0 points. Maximum DVSS score is 30 points.	1.5 years
Number of Patients with Osteoporosis	4. Rates of osteopenia and osteoporosis, as determined by bone density Z-score using DEXA scan of pelvis and sacral spine. Osteopenia is defined as a z-score between - 1 to -2.5, while osteoporosis is defined as a z-score below -2.5	1.5 years
DEXA Scan Results	3. Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.	1.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker - ATP	Measure biomarker ATP in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Biomarker - NGF	Measure biomarker NGF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Biomarker - BNDF	Measure biomarker BNDF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Biomarker - urine proteomic screening results	Measure urinary excreted proteins and peptides via urine proteomic screening in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Michael Edwards, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Clinical Chemistry Tests; Urinalysis
• Other Study ID Numbers: 22-1533.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No