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NCT01733953 · ClinicalTrials.gov registry record · Phase 2
Statin Therapy in Young Adult Survivors of Childhood Cancer
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01733953 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 27 participants.
The verdict
NCT01733953, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Adult survivors of childhood cancer are at high risk of developing cardiovascular disease. Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage to the surface of the artery wall called the endothelial layer, leading to the induction of atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase inhibitors, or statins, improve endothelial function independent of cholesterol-lowering. In addition, statins have been shown to reduce arterial stiffness and slow arterial thickening. Despite strong evidence supporting the vascular benefits of statins in many different patient populations, these medications have never been studied in cancer survivors. Therefore, the overall objective of this study is to evaluate the effects of statin therapy on vascular health in young adult survivors of childhood cancer. Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized, double-blind (participants and investigators), placebo-controlled pilot clinical trial comparing the effects of atorvastatin versus placebo on endothelial function and other measures of vascular health. Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit artery endothelial function in young adult survivors of childhood cancer. The investigators hypothesize that, compared to placebo, atorvastatin will significantly increase brachial artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and non-Hodgkin's lymphoma.
Interventions
- DRUG Atorvastatin
- DRUG Sugar Pill (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01733953
The ClinicalTrials.gov registry entry for NCT01733953 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atorvastatin is the first listed.
NCT01733953 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01733953 about?
NCT01733953 is a clinical study titled "Statin Therapy in Young Adult Survivors of Childhood Cancer". Adult survivors of childhood cancer are at high risk of developing cardiovascular disease. Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage to the surface of the artery wall called the endothelial layer, leading to the induction of atherosclerosis and eve...
What is the current status of trial NCT01733953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2012-11. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01733953?
The interventions under investigation include: Atorvastatin (DRUG), Sugar Pill (Placebo) (DRUG).
Who is sponsoring clinical trial NCT01733953?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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