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

Completed

• Conditions: Myelodysplastic Syndrome; Leukemia; Acute Myeloid Leukemia; Hematological Malignancy; Lymphoma; Myeloma
• Interventions: 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

• Registration Number: NCT02598752
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Status Verified: 2020-04
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
functional performance testing	Resting assessment of cardiac function by echocardiography	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.
functional performance testing	Post-exercise assessment of cardiac function by echocardiography	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.
functional performance testing	Patient-reported outcomes questionnaire	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.
functional performance testing	Symptom-limited cardiopulmonary exercise test (CPET)	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.
functional performance testing	Pulmonary function	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.

Primary Outcome Measures

Name	Time	Method
VO2peak	1 year	is a measure determined by the CPET

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States