A Phase 2 interventional study of Vapotherm and BIPAP in Advanced Cancers, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-02.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
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.
681 studies on the registry are indexed under Dyspnea; 159 are open to participants now.
This study's enrollment of 30 is below the median of 48 across 447 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
Device: Vapotherm · Device: BIPAP
Vapotherm air delivery then BiPAP.
Device: Vapotherm · Device: BIPAP
Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.
Also known as: High flow oxygen delivery system
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.
Also known as: Bilevel positive airway pressure device
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.
Time frame: 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.
Time frame: Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)
Recruitment period August 2009 to February 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
| Milestone | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Started | 15 | 15 |
| Completed | 10 | 13 |
| Not completed | 5 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Treatment delivery order switched | 1 | 0 |
| Milestone | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Started | 10 | 13 |
| Completed | 3 | 8 |
| Not completed | 7 | 5 |
| Withdrew: Patient preference | 1 | 3 |
| Withdrew: Pain | 1 | 0 |
| Withdrew: Too tired | 1 | 0 |
| Withdrew: Dyspnea too low to continue | 4 | 2 |
| Milestone | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Started | 3 | 8 |
| Completed | 3 | 5 |
| Not completed | 0 | 3 |
| Withdrew: Claustrophobia/anxiety | 0 | 3 |
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.
| Participants | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Completed washout period | 7 | 10 |
| Completed second intervention | 3 | 5 |
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.
| units on a scale | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Dyspnea NRS at the time of enrollment | 7 (5 to 8) | 6 (4 to 8) |
| Dyspnea NRS after intervention | 3.4 (1.8 to 5.0) | 4.2 (3.1 to 5.4) |
Collected over Study participation time was approximately 5 hours, from enrollment till second air delivery treatment completed. Total study period was 2 years and 4 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group1: BiPAP Then Vapotherm | — | 0/15 (0%) | 15/15 (100%) |
| Group 2: Vapotherm Then BiPAP | — | 0/15 (0%) | 15/15 (100%) |
| Event | Group1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP |
|---|---|---|
| Trouble sleeping before interventionGeneral disorders | 2/15 | 7/15 |
| Trouble talking before interventionSocial circumstances | 2/15 | 6/15 |
| Trouble eating before interventionGastrointestinal disorders | 2/15 | 5/15 |
| Dry eyes before interventionEye disorders | 1/15 | 3/15 |
| Eye irritation before interventionEye disorders | 1/15 | 3/15 |
| Stomach bloating before interventionGastrointestinal disorders | 1/15 | 3/15 |
| Anxiety before interventionPsychiatric disorders | 2/15 | 1/15 |
| Moist nose before interventionGeneral disorders | 2/15 | 2/15 |
| Prong Uncomfortable before interventionGeneral disorders | 2/15 | 2/15 |
| Suffocating before interventionRespiratory, thoracic and mediastinal disorders | 1/15 | 1/15 |
| Age, Continuous(years) | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP | Total |
|---|---|---|---|
| Mean | 63 (47 to 79) | 59 (29 to 79) | 61 (29 to 79) |
| Sex: Female, Male(Participants) | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 9 | 5 | 14 |
| Race (NIH/OMB)(Participants) | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 11 | 12 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Group 1: BiPAP Then Vapotherm | Group 2: Vapotherm Then BiPAP | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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