Effects of pelvic radiation therapy on bladder and bone health in childhood cancer survivors
Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer
This study is trying to see if childhood cancer survivors who had pelvic radiation therapy have more problems with bladder function and weaker bones compared to those who only had chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 40 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05818462 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization in childhood cancer survivors. It hypothesizes that patients who received EBRT will experience higher rates of LUT dysfunction and osteoporosis compared to those who received similar chemotherapy without EBRT. The study will utilize patient-reported outcomes and direct measures such as uroflow testing, bladder scans, and DEXA scans to assess these effects. Participants will be compared to a control group of patients with similar chemotherapy regimens but without pelvic radiation exposure.
Who should consider this trial
Good fit: Ideal candidates are childhood cancer survivors who received chemotherapy for solid tumors and pelvic radiation therapy at least one year prior to enrollment.
Not a fit: Patients with pre-existing dysfunctional voiding or those who underwent tumor resection of bladder, prostate, or gynecologic organs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for bladder and bone health in childhood cancer survivors.
How similar studies have performed: While the specific focus on pelvic radiation effects in childhood cancer survivors may be novel, similar studies have shown significant impacts of radiation on LUT function and bone health in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado
- Colorado Research Center — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Michael Edwards, MD — Children's Hospital Colorado
- Study coordinator: Michael Edwards, MD
- Email: michael.edwards@childrenscolorado.org
- Phone: 901-326-4341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.