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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Childhood Cancer; Cancer

Treatments: Other: Dysfunctional Voiding Scoring System Survey; Diagnostic Test: DEXA Scan of pelvis and sacral spine; Diagnostic Test: Urine tests for specific biomarkers; Diagnostic Test: Uroflow testing; Diagnostic Test: Bladder Scan

Study type: Observational

Funder types: Other

Identifiers

NCT05818462

22-1533.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 2 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

Patients who received EBRT to the pelvis.

Description:

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.

Treatment:

Diagnostic Test: Bladder Scan

Diagnostic Test: Uroflow testing

Diagnostic Test: Urine tests for specific biomarkers

Diagnostic Test: DEXA Scan of pelvis and sacral spine

Other: Dysfunctional Voiding Scoring System Survey

Control cohort.

Description:

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.

Treatment:

Diagnostic Test: Bladder Scan

Diagnostic Test: Uroflow testing

Diagnostic Test: Urine tests for specific biomarkers

Diagnostic Test: DEXA Scan of pelvis and sacral spine

Other: Dysfunctional Voiding Scoring System Survey