Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST) CREST STUDY

What's the purpose of this trial?

This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.

This trial is currently open and accepting patients.

What will happen during the trial?

PRIMARY OBJECTIVES:

I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.

II. Define the determinants of VO2peak impairment in HCT survivors.

OUTLINE:

Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Age at HCT \>= 18 years
* Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
* Planning to undergo first autologous or allogeneic transplant
* Able to fluently read and write in English
* Able to understand and sign the study specific informed consent form (ICF)
* Physically able and willing to complete all study procedures

Exclusion Criteria:

* Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
* Unstable angina or history of acute myocardial Infarction (\< 5 days of any planned study procedures)
* Recurrent syncope
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled arrhythmia causing symptoms
* Pulmonary embolus \< 3 month of study procedures
* Thrombosis of lower extremities
* Moderate or severe persistent asthma (National Asthma Education \& Prevention)
* Room air desaturation at rest =\< 85%
* Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
* Anemia (hemoglobin \[Hgb\] \< 8 g/dL)

Additional Trial Information

Enrollment: 350 patients (estimated)

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Trial Locations

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California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting
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