Phase 2
N=30
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer
Advanced Cancers
Bottom Line
View on ClinicalTrials.gov: NCT00934128 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Participants Completing Study Intervention — 7; 10; 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vapotherm (Device); BIPAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing Study Intervention |
7; 10; 3; 5 | — |
| PRIMARY Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale |
7; 6; 3.4; 4.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Patients who remain hypoxic (i.e. O2 saturation 140, systolic blood pressure (SBP) 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.
Data sourced from ClinicalTrials.gov (NCT00934128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.