High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer

Completed · Phase 2

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath. The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.

Key facts

Study ID

NCT00934128

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2009-08-01

Expected to finish

2012-11-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of advanced cancer, defined as locally advanced, recurrent or metastatic disease
• Patients with persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >/=3 out of a Numeric Rating Scale from 0 to 10 for at least 2 week and just prior to study initiation, despite supplemental oxygen of up to 21 L/min to keep oxygen saturation >/=90%
• Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or without obstructive lung disease
• Inpatient at MD Anderson Cancer Center
• Patients with cancer treatment related dyspnea are eligible for this study if they meet the eligibility criteria above.
• Able to communicate in English
• Expected life expectancy >1 week
• Patients with a diagnosis of pneumonia are also eligible for this study if they meet the eligibility criteria above, with dyspnea >=2 weeks prior to the diagnosis of pneumonia.
• Age 18 or greater

You may not qualify if…

• Patients who remain hypoxic (i.e. O2 saturation <90% despite maximal oxygen delivery (21 L/min) are not included in this study because they are considered to have severe life-threatening respiratory failure and are too unstable for study inclusion.
• Hemodynamic instability (Heart Rate (HR) >140, systolic blood pressure (SBP) <80) within 24 hours of study initiation (as per Clinic Station)
• Acute respiratory distress requiring intubation
• Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher
• Glasglow coma scale <8
• Excessive airway secretions interfering with BIPAP administration
• History of facial trauma within 1 month of enrollment
• Upper GI bleed within 2 weeks of enrollment or esophageal rupture
• Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea >7/10) within 48 hours of enrollment
• Hemoglobin <8 g/dL at the time of enrollment (blood draw within last 2 weeks)
• Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical
• Unwilling to provide informed consent
• Diagnosis of non-cancer related dyspnea (e.g. Chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) or any chronic respiratory disease) requiring supplemental home oxygen prior to hospitalization.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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