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

NCT ID: NCT02598752

Last Updated: 2020-04-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome Hematological Malignancy Leukemia Lymphoma Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type OTHER

Resting assessment of cardiac function by echocardiography

Intervention Type OTHER

Post-exercise assessment of cardiac function by echocardiography

Intervention Type OTHER

Pulmonary function

Intervention Type OTHER

Patient-reported outcomes questionnaire

Intervention Type BEHAVIORAL

Interventions

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Symptom-limited cardiopulmonary exercise test (CPET)

Intervention Type OTHER

Resting assessment of cardiac function by echocardiography

Intervention Type OTHER

Post-exercise assessment of cardiac function by echocardiography

Intervention Type OTHER

Pulmonary function

Intervention Type OTHER

Patient-reported outcomes questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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15-274

Identifier Type: -

Identifier Source: org_study_id

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