Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02598752

Collaborator

(none)

Enrollment

Location

53.3

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Hematological Malignancy Leukemia Lymphoma Myeloma	Other: Symptom-limited cardiopulmonary exercise test (CPET) Other: Resting assessment of cardiac function by echocardiography Other: Post-exercise assessment of cardiac function by echocardiography Other: Pulmonary function Behavioral: Patient-reported outcomes questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Apr 10, 2020

Actual Study Completion Date :

Apr 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Symptom-limited cardiopulmonary exercise test (CPET) Other: Resting assessment of cardiac function by echocardiography Other: Post-exercise assessment of cardiac function by echocardiography Other: Pulmonary function Behavioral: Patient-reported outcomes questionnaire

Arm

Intervention/Treatment

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.

Other: Symptom-limited cardiopulmonary exercise test (CPET)

Other: Resting assessment of cardiac function by echocardiography

Other: Post-exercise assessment of cardiac function by echocardiography

Other: Pulmonary function

Behavioral: Patient-reported outcomes questionnaire

Outcome Measures

Primary Outcome Measures

VO2peak [1 year]
is a measure determined by the CPET

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with MSK histologically confirmed hematologic malignancy
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:

Any of the following absolute contraindications to cardiopulmonary exercise testing
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