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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598752
• Other study ID #: 15-274
• Status: Completed
• Start date: November 2015
• Est. completion date: April 10, 2020

Study information

• Verified date: April 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Hematologic Neoplasms
• Hematological Malignancy
• Leukemia
• Lymphoma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myeloma

Intervention

Other:
• Symptom-limited cardiopulmonary exercise test (CPET)

• Resting assessment of cardiac function by echocardiography

• Post-exercise assessment of cardiac function by echocardiography

• Pulmonary function

Behavioral:
• Patient-reported outcomes questionnaire

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2peak	is a measure determined by the CPET	1 year

External Links

•   Memorial Sloan Kettering Cancer Center