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

University of Colorado, Denver32 enrolled

Overview

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 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

Conditions

Cancer Childhood Cancer

Interventions

Uroflow testingDIAGNOSTIC_TEST

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 ScanDIAGNOSTIC_TEST

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.

Dysfunctional Voiding Scoring System SurveyOTHER

The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Colorado Research Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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)

Time frame: 1.5 years

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 1.5 years

Data from ClinicalTrials.gov

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