Advanced Cancers
Conditions
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
Brief 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.
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.
Interventions
DEVICEVapotherm
Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.
DEVICEBIPAP
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of advanced cancer, defined as locally advanced, recurrent or metastatic disease 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 pneumonia. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Study Intervention | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period August 2009 to February 2012. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: BiPAP Then Vapotherm Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery. | 15 |
| Group 2: Vapotherm Then BiPAP Vapotherm air delivery then BiPAP. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (2 Hours) | Adverse Event | 4 | 1 |
| First Intervention (2 Hours) | Treatment Delivery Order Switched | 1 | 0 |
| First Intervention (2 Hours) | Withdrawal by Subject | 0 | 1 |
| Second Intervention (2 Hours) | Claustrophobia/anxiety | 0 | 3 |
| Washout Period (1 Hour) | Dyspnea too low to continue | 4 | 2 |
| Washout Period (1 Hour) | Pain | 1 | 0 |
| Washout Period (1 Hour) | Patient preference | 1 | 3 |
| Washout Period (1 Hour) | Too tired | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: Vapotherm Then BiPAP | Total | Group 1: BiPAP Then Vapotherm |
|---|---|---|---|
| Age, Continuous | 59 years | 61 years | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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)
Population: One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: BiPAP Then Vapotherm | Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale | Dyspnea NRS at the time of enrollment | 7 units on a scale |
| Group 1: BiPAP Then Vapotherm | Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale | Dyspnea NRS after intervention | 3.4 units on a scale |
| Group 2: Vapotherm Then BiPAP | Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale | Dyspnea NRS at the time of enrollment | 6 units on a scale |
| Group 2: Vapotherm Then BiPAP | Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale | Dyspnea NRS after intervention | 4.2 units on a scale |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: BiPAP Then Vapotherm | Number of Participants Completing Study Intervention | Completed washout period | 7 Participants |
| Group 1: BiPAP Then Vapotherm | Number of Participants Completing Study Intervention | Completed second intervention | 3 Participants |
| Group 2: Vapotherm Then BiPAP | Number of Participants Completing Study Intervention | Completed second intervention | 5 Participants |
| Group 2: Vapotherm Then BiPAP | Number of Participants Completing Study Intervention | Completed washout period | 10 Participants |