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OpenTrials
Completed

NCT Number: NCT02598752

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Patient-reported outcomes questionnaire

Behavioral

Primary outcomes

  1. VO2peak

    Time frame: 1 year

    is a measure determined by the CPET

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2015
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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