Advanced CancersPhase 2NCT01518140
BiPAP-Vapotherm RCT
A Phase 2 study testing Oxygen Delivery Devices and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also 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?
- Oxygen Delivery Devices and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of advanced cancer, defined as locally advanced, recurrent, or metastatic disease
- Persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >=3/10 on the numeric rating scale for at least 1 week and just prior to study initiation despite supplemental oxygen for at least 30 minutes
- Dyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease
- Inpatient at MD Anderson Cancer Center
- Able to communicate in English
- Expected life expectancy >1 week
- Age 18 or older
Who cannot join
- Hypoxia (i.e., O2 saturation <90%) despite supplemental oxygen at 15 L/min
- Hemodynamic instability (systemic blood pressure (SBP) <90 mmHg) within 1 hour of study initiation
- Comatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher
- Uncontrolled arrhythmia as per clinical record at enrollment
- Upper GI bleeding within 2 weeks of enrollment
- Esophageal rupture at enrollment
Show all 18Show fewer
- Upper airway obstruction at enrollment
- History of facial trauma within 2 weeks of enrollment
- Facial, upper airway, or GI surgery within 2 weeks of enrollment
- Thoracic surgery within 6 weeks of enrollment
- Excessive airway secretions interfering with BiPAP administration
- Undrained pneumothorax at enrollment
- Partial or complete small bowel obstruction or severe nausea/vomiting (Edmonton symptom assessment scale nausea >7/10) within 48 hours of enrollment
- Hemoglobin <8 g/dL at the time of enrollment (blood drawn within past 2 weeks)
- Acute exacerbation of chronic obstructive pulmonary disease (COPD) or heart failure within 1 week of enrollment by history or physical
- Known CO2 retainers as per clinic station
- Known pulmonary hypertension as per clinic station
- Unwillingness to provide consent
About this study
Official title: Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer
The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.
Read the detailed description
Device A is designed to 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.
Device B is 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.
Device C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.
Study Groups and Device Use:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:
- If you are in Group 1, you will receive air through Device A for 1 hour, and then on an "as needed" basis for up to 4 hours. Then you will receive air through Device B for up to 30 minutes, followed by 30 minutes using Device C.
- If you are in Group 2, you will receive air through Device B for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device C.
- If you are in Group 3, you will receive air through Device C for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device B.
The study staff will help you use the devices. The maximum time allowed using the 3 devices is 6 hours total.
During the "as needed" use period (4 hours), you will switch between the device you were assigned to and the same air delivery device and oxygen level that you were using just before you started the study.
Study Visit:
During your study visit, the following tests and procedures will be performed:
- From your medical record, the study staff will collect information about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
- You will complete 2 questionnaires. The first asks about breathing symptoms, and the second asks about other symptoms you may be having. It should take about 15 minutes to complete these questionnaires.
- Your heart rate, breathing rate, and blood pressure will be recorded.
- The level of air you breathe out will be recorded using a measuring device on your chest.
- Before and after using the devices, you will be asked how hard it is to catch your breath and about any side effects you may be having.
- At the end of the visit, you will fill out a questionnaire that asks about which device you prefer. It should take about 5 minutes to complete this questionnaire.
Length of Study:
You will be on this study for up to 6 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.
This is an investigational study. The 3 breathing devices are commercially available and FDA approved for delivering oxygen when medically needed, including in cancer patients. It is investigational to collect information from patients to rate how well the study devices may affect shortness of breath.
Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Oxygen Delivery Devices, Questionnaires
- Keywords
- Advanced Cancers, Locally advanced, Recurrent, Metastatic disease, Oxygen Delivery Modalities, Shortness of breath, Dyspnea, VapoTherm, Bilevel positive airway pressure, BiPAP, Non-rebreather mask
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Delivery DevicesDevice
Participants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.
QuestionnairesBehavioural
Also called Surveys
2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| VapoTherm | Experimental | Participants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask. Receives: Device: Oxygen Delivery Devices; Behavioral: Questionnaires |
| BiPAP | Experimental | Participants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask. Receives: Device: Oxygen Delivery Devices; Behavioral: Questionnaires |
| Non-Rebreather Mask | Experimental | Participants receive air through Non-Rebreather Mask for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP). Receives: Device: Oxygen Delivery Devices; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 3 Different Oxygen Delivery Methods
Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01518140
- Sponsor's protocol ID
- 2011-0689
- Status last verified
- Aug 2013
- First submitted
- 23 Jan 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hui D, Morgado M, Chisholm G, Withers L, Nguyen Q, Finch C, Frisbee-Hume S, Bruera E. High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: a phase II randomized trial. J Pain Symptom Manage. 2013 Oct;46(4):463-73. doi: 10.1016/j.jpainsymman.2012.10.284. Epub 2013 Jun 2.
PubMed 23739633
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01518140
- Acronym / sponsor ID
- 2011-0689
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Locally advanced, Recurrent, Metastatic disease, Oxygen Delivery Modalities, Shortness of breath, Dyspnea, VapoTherm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2019 (estimated)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
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 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.
Detailed description
Device A is designed to 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.
Device B is 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.
Device C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.
Study Groups and Device Use:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:
- If you are in Group 1, you will receive air through Device A for 1 hour, and then on an "as needed" basis for up to 4 hours. Then you will receive air through Device B for up to 30 minutes, followed by 30 minutes using Device C.
- If you are in Group 2, you will receive air through Device B for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device C.
- If you are in Group 3, you will receive air through Device C for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device B.
The study staff will help you use the devices. The maximum time allowed using the 3 devices is 6 hours total.
During the "as needed" use period (4 hours), you will switch between the device you were assigned to and the same air delivery device and oxygen level that you were using just before you started the study.
Study Visit:
During your study visit, the following tests and procedures will be performed:
- From your medical record, the study staff will collect information about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
- You will complete 2 questionnaires. The first asks about breathing symptoms, and the second asks about other symptoms you may be having. It should take about 15 minutes to complete these questionnaires.
- Your heart rate, breathing rate, and blood pressure will be recorded.
- The level of air you breathe out will be recorded using a measuring device on your chest.
- Before and after using the devices, you will be asked how hard it is to catch your breath and about any side effects you may be having.
- At the end of the visit, you will fill out a questionnaire that asks about which device you prefer. It should take about 5 minutes to complete this questionnaire.
Length of Study:
You will be on this study for up to 6 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.
This is an investigational study. The 3 breathing devices are commercially available and FDA approved for delivering oxygen when medically needed, including in cancer patients. It is investigational to collect information from patients to rate how well the study devices may affect shortness of breath.
Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VapoTherm | Experimental | Device: Oxygen Delivery Devices, Behavioral: QuestionnairesParticipants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask. |
| BiPAP | Experimental | Device: Oxygen Delivery Devices, Behavioral: QuestionnairesParticipants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask. |
| Non-Rebreather Mask | Experimental | Device: Oxygen Delivery Devices, Behavioral: QuestionnairesParticipants receive air through Non-Rebreather Mask for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of advanced cancer, defined as locally advanced, recurrent, or metastatic disease
- Persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level >=3/10 on the numeric rating scale for at least 1 week and just prior to study initiation despite supplemental oxygen for at least 30 minutes
- Dyspnea judged clinically to be predominantly due to the underlying malignancy, with or without obstructive lung disease
- Inpatient at MD Anderson Cancer Center
- Able to communicate in English
Key exclusion criteria (18 listed)
- Hypoxia (i.e., O2 saturation <90%) despite supplemental oxygen at 15 L/min
- Hemodynamic instability (systemic blood pressure (SBP) <90 mmHg) within 1 hour of study initiation
- Comatose state or delirium, as indicated by a Memorial Delirium Assessment Scale score of 13 or higher
- Uncontrolled arrhythmia as per clinical record at enrollment
- Upper GI bleeding within 2 weeks of enrollment
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 |
|---|---|---|
| Oxygen Delivery DevicesParticipants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask. | Device | BiPAP, Non-Rebreather Mask, VapoTherm |
| QuestionnairesAlso: Surveys2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete. | Behavioural | BiPAP, Non-Rebreather Mask, VapoTherm |
Primary outcome
Efficacy of 3 Different Oxygen Delivery Methods
Time frame: 6 hours
Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Derived from this study: PubMed 23739633Hui D, Morgado M, Chisholm G, Withers L, Nguyen Q, Finch C, Frisbee-Hume S, Bruera E. High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: a phase II randomized trial. J Pain Symptom Manage. 2013 Oct;46(4):463-73. doi: 10.1016/j.jpainsymman.2012.10.284. Epub 2013 Jun 2.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxygen Delivery Devices and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center.
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 7 inclusion and 18 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: withdrawn, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of 3 Different Oxygen Delivery Methods (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518140, which also lists 1 linked publication.
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 13 Aug 2013.