Actively Recruiting Clinical Trials Investigating Late Effects in Childhood Cancer Survivors


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The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients who are survivors of childhood cancer who may be experiencing late effects of their treatment. The trials are investigating early detection of cardiac complications; assessing insulin sensitivity and diabetes risk; pharmacologic intervention for cardiac complications; improving lean muscle mass; detection of endocrine abnormalities; bone mineral density; neurocognitive deficits; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

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.



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