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An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients

Phase 2
18 Years
Not Enrolling
Advanced Cancers

Thank you

Trial Information

An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients

Study Devices:

The BiPAP device is designed to help people get more air in and out of their lungs without
using as much effort as regular breathing. The air is given through a mask, and the amount
of air can be set to different levels.

The Vapotherm device is also designed to deliver air in and out of the lungs. The air is
warmed, filtered for bacteria, and then delivered through the nose using a tube under the

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups.

- Group 1 will receive air through BiPAP for up to 2 hours and then air through Vapotherm
for up to 2 hours.

- Group 2 will receive air through Vapotherm for up to 2 hours and then air through BiPAP
for up to 2 hours.

The study staff will help you use the devices.

If you have trouble with one of the devices, you can be switched to the other device before
the 2-hour period is over.

After using the first device, you will wait for up to 60 minutes before switching over to
the other device. This waiting period will occur no matter if you used the first device for
the full 2 hours or not.

During the waiting period, you will return to the same air delivery device and oxygen level
that you were using just before you started the study. The study staff will also be
checking to see if you are still eligible to use the second device.

Study Tests:

During the study period, your vital signs and level of air breathed out will be recorded
using a measuring device on your chest.

Before and after using the devices, you will rate how hard it is to catch your breath.

After using the second device, you will fill out a questionnaire that has questions about
which device you prefer. This should take less than 5 minutes.

Length of Study:

You will be on this study for up to 5 hours. You will be taken off study and the device
will be stopped if intolerable side effects occur while using a study device.

Use of Other Drugs:

During the 4-5 hour study period, you will not be allowed to take certain drugs for standard
care that may affect the study tests. These drugs include certain pain-killer drugs (such
as morphine and hydromorphone), steroids (such as prednisone and dexamethasone), and inhaled
drugs (such as ipratropium and salbutamol).

Any doses of inhaled drugs (regularly scheduled doses and "as needed" doses) and any "as
needed" doses of pain-killer drugs and steroids that fall within the 4-5 hour study period
will be put on hold and will be given to you right after the study is complete.

You may, however, choose to take these drugs, either because your shortness of breath is not
controlled, or because these drugs are needed to treat other problems (such as pain). If
you and your doctor decide that you should take these drugs during the study period, you
will be taken off study so you can receive these drugs. The reason for stopping your study
participation is that these drugs may affect how you rate your shortness of breath.

This is an investigational study. The BIPAP and Vapotherm devices are commercially
available and FDA approved for delivering oxygen when medically needed, including in
patients with advanced cancer. The investigational part of this study is to collect
information from asking patients to rate how well the study devices may affect shortness of

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. History of advanced cancer, defined as locally advanced, recurrent or metastatic

2. 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%

3. Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or
without obstructive lung disease

4. Inpatient at MD Anderson Cancer Center

5. Patients with cancer treatment related dyspnea are eligible for this study if they
meet the eligibility criteria above.

6. Able to communicate in English

7. Expected life expectancy >1 week

8. 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

9. Age 18 or greater

Exclusion Criteria:

1. 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.

2. Hemodynamic instability (Heart Rate (HR) >140, systolic blood pressure (SBP) <80)
within 24 hours of study initiation (as per Clinic Station)

3. Acute respiratory distress requiring intubation

4. Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher

5. Glasglow coma scale <8

6. Excessive airway secretions interfering with BIPAP administration

7. History of facial trauma within 1 month of enrollment

8. Upper GI bleed within 2 weeks of enrollment or esophageal rupture

9. Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea
>7/10) within 48 hours of enrollment

10. Hemoglobin <8 g/dL at the time of enrollment (blood draw within last 2 weeks)

11. Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical

12. Unwilling to provide informed consent

13. 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ESAS Dyspnea Numeric Score (ESAS=Edmonton Symptom Assessment Scale)

Outcome Description:

Dyspnea is a subjective sensation experienced by participants. ESAS Numeric Rating Scale (0=no dyspnea and 10=worst dyspnea) shows the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.

Outcome Time Frame:

5 hours

Safety Issue:


Principal Investigator

David Hui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

November 2012

Related Keywords:

  • Advanced Cancers
  • Advanced Cancer
  • Persistent Dyspnea
  • Shortness of breath
  • Specialized breathing devices
  • Bilevel positive airway pressure device
  • High flow oxygen delivery device
  • VapoTherm
  • Edmonton Symptom Assessment Scale
  • ESAS
  • Dyspnea
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030