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

Recruiting
Conditions
Childhood Cancer
Cancer
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.

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.
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Uroflow and Bladder Scan Results1.5 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
NameTimeMethod
DEXA Scan Results1.5 years

3. Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.

DVSS Scores1.5 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 Osteoporosis1.5 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

Colorado Research Center
🇺🇸Aurora, Colorado, United States
Michael Edwards
Contact
michael.edwards@childrenscolorado.org

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