PILOT

Study Title: Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To evaluate a high blood pressure monitor–based intervention for the early detection of prehypertension and prevention of clinical hypertension in survivors of childhood cancer

Primary Outcome Measures: Proportion of participants who meet or exceed defined minimum use of high blood pressure monitoring device by group [time frame: from day 0 through 3 months]

Principal Investigator: Todd M. Gibson, PhD, St. Jude Children’s Research Hospital; 866-278-5833, referralinfo@stjude.org

ClinicalTrials.gov Identifier: NCT02476162

Study Title: Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study

Study Type: Observational/cohort/cross-sectional

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children

Primary Outcome Measures: Characterize β-cell function, insulin sensitivity [time frame: 2 years]

Principal Investigator: Danielle N. Friedman, MD, Memorial Sloan Kettering Cancer Center; 212-639-7376

ClinicalTrials.gov Identifier: NCT02248779

PHASE II

Study Title: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: City of Hope Medical Center, National Cancer Institute

Purpose: To study the side effects and how well low-dose carvedilol works in preventing congestive heart failure in younger cancer survivors exposed to high-dose anthracyclines for management of childhood cancer

Primary Outcome Measures: Left-ventricular wall thickness–dimension ratio, reported in terms of left-ventricular posterior wall dimension in systole and left-ventricular dimension based on the internal diameter in diastole [time frame: up to 24 months]

Principal Investigator: Saro ­Armenian, DO, MPH, City of Hope Medical Center; 626-471-7320, sarmenian@coh.org

ClinicalTrials.gov Identifier: NCT01347970

OTHER

Study Title: Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital, ATC Fitness, American Institute for Cancer Research

Purpose: To evaluate the effects of resistance training combined with either a protein supplement or an energy drink on changes in lean muscle mass in young adults who were treated for childhood cancer

Primary Outcome Measures: Change in lean muscle mass by arm; change in handgrip by arm; change in knee extension by arm; change in ankle dorsiflexion by arm; change in walking speed by arm; change in endurance by arm; change in activity level by arm; change in blood pressure by arm; change in high-density lipoprotein by arm; change in trigylcerides by arm; change in abdominal obesity by arm; change in fasting glucose by arm; change in fasting insulin by arm; change in C-reactive protein by arm; change in self-reported exhaustion by arm [time frame: baseline and at 24 weeks]

Principal Investigator: Kirsten K. Ness, PT, PhD, St. Jude Children’s Research Hospital; 866-278-5833, referralinfo@stjude.org

ClinicalTrials.gov Identifier: NCT02501460

Study Title: Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoietic Stem Cell Transplant Recipients

Study Type: Observational

Study Sponsor and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health Clinical Center

Purpose: To determine the prevalence of endocrine-related side effects in children who have been treated for cancer and establish a database and registry organized according to cancer diagnosis, treatments, and endocrine side effects

Principal Investigator: Maya B. Lodish, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; 301-451-7175, lodishma@mail.nih.gov

ClinicalTrials.gov Identifier: NCT00504218

Study Title: Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Dana-Farber Cancer Institute

Purpose: To evaluate bone mineral density in childhood cancer survivors who have a history of bone fracture

Primary Outcome Measures: Total body bone mineral density (total body less head) and lumbar spine bone mineral density, volumetric bone mineral density of distal radius [time frame: participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy]

Principal Investigator: Lynda Vrooman, MD, Dana-Farber Cancer Institute; 617-632-2659, lyndra_vrooman@dfci.harvard.edu

ClinicalTrials.gov Identifier: NCT02355340

Study Title: Melatonin Intervention for Neurocognitive Deficits in the St. Jude Lifetime Cohort

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital, National Cancer Institute

Purpose: To examine the efficacy of melatonin treatment on neurocognitive functioning and delayed sleep onset latency in long-term/adult survivors of childhood cancer

Primary Outcome Measures: Neurocognitive function as measured by performance on standardized tests of attention, memory, and executive function [time frame: baseline and 6 months after start of therapy]

Principal Investigator: Tara ­Brinkman, PhD, St. Jude Children’s Research Hospital; 866-278-5833, referralinfo@stjude.org

ClinicalTrials.gov Identifier: NCT01700959 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.