Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
NCT ID: NCT02598752
Last Updated: 2020-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2015-11-30
2020-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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functional performance testing
This observational study will evaluate the feasibility and safety of functional performance testing in patients undergoing HCT. In addition to standard of care procedures, participants will undergo a CPET with a rest and stress echo, pulmonary function, and patient reported outcome questionnaires within 30 days of HCT.
Symptom-limited cardiopulmonary exercise test (CPET)
Resting assessment of cardiac function by echocardiography
Post-exercise assessment of cardiac function by echocardiography
Pulmonary function
Patient-reported outcomes questionnaire
Interventions
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Symptom-limited cardiopulmonary exercise test (CPET)
Resting assessment of cardiac function by echocardiography
Post-exercise assessment of cardiac function by echocardiography
Pulmonary function
Patient-reported outcomes questionnaire
Eligibility Criteria
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Inclusion Criteria
* Scheduled for autologous or allogenic HCT at MSKCC
* ≥21 years old
* ECOG performance status of 0 or 1
* Completion of baseline CPET
* Willing to comply with protocol related procedures
Exclusion Criteria
* Acute myocardial Infarction (within 3-5 days of any planned study procedures)
* Unstable angina
* Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
* Recurrent syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary edema
* Respiratory failure
* Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
* Presence of any other concurrent, actively treated malignancy;
* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
* Room air desaturation at rest ≤85%
* Mental impairment leading to inability to cooperate
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jessica Scott, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-274
Identifier Type: -
Identifier Source: org_study_id
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