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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818462
• Other study ID #: 22-1533.cc
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Michael Edwards, MD
• Phone: 901-326-4341
• Email: michael.edwards[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Childhood Cancer

Intervention

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.
• 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.
• Urine tests for specific biomarkers
Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).

Locations

Country	Name	City	State
United States	Colorado Research Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker - ATP	Measure biomarker ATP in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Other	Biomarker - NGF	Measure biomarker NGF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Other	Biomarker - BNDF	Measure biomarker BNDF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.	1.5 years
Other	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
Primary	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	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
Secondary	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
Secondary	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