Advanced CancersPhase 2NCT00934128
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer
A Phase 2 study testing Vapotherm and BIPAP in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Vapotherm and BIPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients
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.
Read the detailed description
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 nostrils.
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 breath.
Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Vapotherm, BIPAP
- Keywords
- Advanced Cancer, Persistent Dyspnea, Shortness of breath, Specialized breathing devices, Bilevel positive airway pressure device, BIPAP, High flow oxygen delivery device, VapoTherm, Edmonton Symptom Assessment Scale, ESAS
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapothermDevice
Also called High flow oxygen delivery system
Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.
BIPAPDevice
Also called Bilevel positive airway pressure device
Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: BiPAP then Vapotherm | Experimental | Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery. Receives: Device: Vapotherm; Device: BIPAP |
| Group 2: Vapotherm then BiPAP | Experimental | Vapotherm air delivery then BiPAP. Receives: Device: Vapotherm; Device: BIPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing Study Intervention
Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.
A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour.
Measured: Minimally 1 hour, up to 5 hours
Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale
Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.
Measured: Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934128
- Sponsor's protocol ID
- 2009-0164
- Status last verified
- Feb 2016
- First submitted
- 7 Jul 2009
- Last updated
- 2 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00934128
- Acronym / sponsor ID
- 2009-0164
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancer, Persistent Dyspnea, Shortness of breath, Specialized breathing devices, Bilevel positive airway pressure device, BIPAP, High flow oxygen delivery device, VapoTherm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 2 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 nostrils.
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 breath.
Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: BiPAP then Vapotherm | Experimental | Device: Vapotherm, Device: BIPAPBilevel positive airway pressure device (BiPAP) then Vapotherm air delivery. |
| Group 2: Vapotherm then BiPAP | Experimental | Device: Vapotherm, Device: BIPAPVapotherm air delivery then BiPAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VapothermAlso: High flow oxygen delivery systemDeliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils. | Device | Group 1: BiPAP then Vapotherm, Group 2: Vapotherm then BiPAP |
| BIPAPAlso: Bilevel positive airway pressure deviceAir given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing. | Device | Group 1: BiPAP then Vapotherm, Group 2: Vapotherm then BiPAP |
Primary outcome
Number of Participants Completing Study Intervention
Time frame: Minimally 1 hour, up to 5 hours
Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study. A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour.
Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale
Time frame: Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)
Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hui, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vapotherm and BIPAP in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing Study Intervention (time frame: Minimally 1 hour, up to 5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.