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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

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

Treatments: Other: Post-exercise assessment of cardiac function by echocardiography; Behavioral: Patient-reported outcomes questionnaire; Other: Resting assessment of cardiac function by echocardiography; Other: Symptom-limited cardiopulmonary exercise test (CPET); Other: Pulmonary function

Study type: Observational

Funder types: Other

Identifiers

NCT02598752

15-274

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

11 participants in 1 patient group

functional performance testing

Description:

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.

Treatment:

Other: Resting assessment of cardiac function by echocardiography

Behavioral: Patient-reported outcomes questionnaire

Other: Symptom-limited cardiopulmonary exercise test (CPET)

Other: Pulmonary function

Other: Post-exercise assessment of cardiac function by echocardiography