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

Recruiting

• Conditions: Childhood Cancer; Cancer
• Interventions: 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

• Registration Number: NCT05818462
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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 Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Study Start: 2023-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who received EBRT to the pelvis.	Bladder Scan	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.
Patients who received EBRT to the pelvis.	Dysfunctional Voiding Scoring System Survey	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.
Patients who received EBRT to the pelvis.	DEXA Scan of pelvis and sacral spine	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.
Control cohort.	DEXA Scan of pelvis and sacral spine	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.
Control cohort.	Urine tests for specific biomarkers	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.
Control cohort.	Uroflow testing	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.
Control cohort.	Bladder Scan	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.
Patients who received EBRT to the pelvis.	Urine tests for specific biomarkers	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.
Patients who received EBRT to the pelvis.	Uroflow testing	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.
Control cohort.	Dysfunctional Voiding Scoring System Survey	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.

Primary Outcome Measures

Name	Time	Method
Uroflow and Bladder Scan Results	1.5 years	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)

Secondary Outcome Measures

Name	Time	Method
DEXA Scan Results	1.5 years	3. Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.
DVSS Scores	1.5 years	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.
Number of Patients with Osteoporosis	1.5 years	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

Trial Locations

Locations (1)

Colorado Research Center; 🇺🇸 Aurora, Colorado, United States