Hematopoietic and Lymphoid Cell NeoplasmNCT02464696
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
A study testing Methylprednisolone, Oxygen Therapy and Positive Air Pressure Device in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how well non-invasive ventilation works in reducing the need for intubation, or placement of a tube in the windpipe, in patients with cancer and respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Methylprednisolone, Oxygen Therapy and Positive Air Pressure Device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2015to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357
- Have a diagnosed malignancy
- Chest radiograph or computed tomography (CT) scan within =< 3 months prior to study enrollment rules out primary or metastatic malignancy in the lungs or pleural space as a significant cause of respiratory insufficiency
- Probability of survival is at least 6 months
Who cannot join
- Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry
- Clinical evidence of left heart failure as the main etiology for respiratory compromise
- Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
- Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure
- Evidence of accessory respiratory muscle use with breathing
- Shock (need for vasopressor therapy or mean arterial pressure [MAP] < 60 despite fluid administration)
Show all 21Show fewer
- Oliguric acute renal failure (urine output < 500 ml/day) unless already on hemodialysis
- Patient already on NIPPV at the time of screening
- pH < 7.30 or partial pressure of carbon dioxide (pCO2) > 50 (if available)
- Fixed upper airway obstruction
- Airway or facial trauma that would hinder the use of a NIPPV mask
- Uncontrolled tachy or bradyarrhythmia or active myocardial ischemia defined as either: atrial fibrillation with rapid ventricular response (heart rate [HR] > 120 beats per minute [bpm]), ventricular tachycardia or nonsustained ventricular tachycardia (any rate), supraventricular tachycardia (any rate), third degree heart block (any rate), heart rate less than 40 beats per minute (regardless of the rhythm)
- Active myocardial ischemia defined as a clinical presentation at the time of screening consistent with acute coronary syndrome which includes unstable angina and electrocardiogram (EKG) changes suggestive of an either an acute ST elevation myocardial infarction (new ST elevations or new left bundle branch block) or acute non-ST elevation myocardial infarction (new ST depressions, new T wave inversions)
- Glasgow Coma Scale (GCS) < 8 or inadequate airway protective reflexes
- Undrained pneumothorax/pneumomediastinum
- Copious secretions (> 20 cc's of sputum production per hour or significant hemoptysis defined as > 100 cc's of hemoptysis in a 24 hour period
- Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
- Recent esophageal, gastric or bowel surgery (within 3 weeks of study enrollment)
- Inability to cooperate with NIPPV
- Refusal to receive NIPPV
- Respiratory arrest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Nisha Rathi, 713-792-5040, NRathi@mdanderson.org
Nisha Rathi
About this study
Official title: A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies
This randomized clinical trial studies how well non-invasive ventilation works in reducing the need for intubation, or placement of a tube in the windpipe, in patients with cancer and respiratory failure. Respiratory failure is a condition in which not enough oxygen passes from the lungs to the blood, and is a common cause of admission to the emergency room in patients with hematological and solid tumor patients. Non-invasive positive pressure ventilation (NIPPV) is a method of delivering oxygen using a mask. It is not yet known whether NIPPV is better at improving the amount of oxygen in the blood, reducing shortness of breath, and the need for intubation than standard high flow oxygen (a tube with 2 prongs placed in the nostrils) in patients with cancer and respiratory failure.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the percent of patients who meet criteria for intubation within 28 days of study inclusion.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (NIPPV THERAPY): Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital.
ARM B (HIGH FLOW OXYGEN THERAPY): Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician.
IDIOPATHIC PULMONARY SYNDROME (IPS) SUBGROUP (INCLUDING DIFFUSE ALVEOLAR HEMORRHAGE): Patients with IPS receive methylprednisolone daily on days 0-48 and every other day (QOD) on days 49-55 in parallel with NIPPV or oxygen therapy, with a taper at the discretion of the treating physician.
After completion of study, patients are followed up until day 100.
- Being tested
- Methylprednisolone, Oxygen Therapy, Positive Air Pressure Device
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Adlone, Caberdelta M, DepMedalone, Depo Moderin
IPS cohort only
Oxygen TherapyProcedure or surgery
Also called supplemental oxygen therapy
Receive high flow oxygen therapy
Positive Air Pressure DeviceDevice
Undergo NIPPV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (NIPPV therapy) | Experimental | Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital. Receives: Drug: Methylprednisolone; Device: Positive Air Pressure Device |
| Arm B (high flow oxygen therapy) | Active comparator | Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician. Receives: Drug: Methylprednisolone; Procedure: Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who require intubation or meet criteria for intubation
Fisher's exact test or a chi-squared test will be used to assess the association between two categorical variables. The intubation rate by 28 days and 95% confidence intervals will be estimated for each treatment arm. Logistic regression will be utilized to assess the effect of patient prognostic factors on the intubation rate by 28 days.
Measured: Up to 28 days from study inclusion
Secondary outcomes (4)
Time to intubation
The Kaplan-Meier method will be used to estimate the time-to-event distribution for each treatment group, and the median time will be provided. The log-rank test will be used to examine the time-to-event distribution of the active treatment group versus that of the control. Time to intubation rate at different time points will be provided by treatment group (i.e. at 7 days, 14 days, 21 days, and 28 days). Since there might be other competing risks for intubation, a competing risk analysis will be performed treating these early events as a competing event for intubation.
Measured: Up to 28 days
Intensive care unit length of stay
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the non-invasive positive pressure ventilation (NIPPV) arm and the control arm.
Measured: Up to 28 days
Hospital length of stay
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.
Measured: Up to 28 days
Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Descriptive statistics, including the mean, standard deviation, median, and range, will be provided. The t-test or Wilcoxon's rank sum test will be used to evaluate the difference between the NIPPV arm and the control arm.
Measured: Baseline up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start6 Oct 2015
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nisha Rathi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464696
- Sponsor's protocol ID
- 2015-0165
- Other IDs
- NCI-2015-01514, 2015-0165
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies
- ClinicalTrials.gov ID
- NCT02464696
- Acronym / sponsor ID
- 2015-0165
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Jun 2015 (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.
This randomized clinical trial studies how well non-invasive ventilation works in reducing the need for intubation, or placement of a tube in the windpipe, in patients with cancer and respiratory failure. Respiratory failure is a condition in which not enough oxygen passes from the lungs to the blood, and is a common cause of admission to the emergency room in patients with hematological and solid tumor patients. Non-invasive positive pressure ventilation (NIPPV) is a method of delivering oxygen using a mask. It is not yet known whether NIPPV is better at improving the amount of oxygen in the blood, reducing shortness of breath, and the need for intubation than standard high flow oxygen (a tube with 2 prongs placed in the nostrils) in patients with cancer and respiratory failure.
Detailed description
PRIMARY OBJECTIVES:
- To determine the percent of patients who meet criteria for intubation within 28 days of study inclusion.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (NIPPV THERAPY): Patients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital.
ARM B (HIGH FLOW OXYGEN THERAPY): Patients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician.
IDIOPATHIC PULMONARY SYNDROME (IPS) SUBGROUP (INCLUDING DIFFUSE ALVEOLAR HEMORRHAGE): Patients with IPS receive methylprednisolone daily on days 0-48 and every other day (QOD) on days 49-55 in parallel with NIPPV or oxygen therapy, with a taper at the discretion of the treating physician.
After completion of study, patients are followed up until day 100.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (NIPPV therapy) | Experimental | Drug: Methylprednisolone, Device: Positive Air Pressure DevicePatients undergo intermittent NIPPV, with the recommended schedule comprising 2 hours on NIPPV followed by =< 2 hours off NIPPV and continuous NIPPV at night or while sleeping for 8 hours per day, for 28 days or until discharged from the hospital. |
| Arm B (high flow oxygen therapy) | Active comparator | Drug: Methylprednisolone, Procedure: Oxygen TherapyPatients continue to receive high flow nasal cannula oxygen therapy using current protocol for titration of high flow oxygen therapy for 28 days or until discharged from the hospital. Patients may receive NIPPV if they develop evidence of accessory muscle use with breathing or at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio =< 300 mmHg OR a peripheral capillary oxygen saturation (SaO2):FiO2 =< 357
- Have a diagnosed malignancy
- Chest radiograph or computed tomography (CT) scan within =< 3 months prior to study enrollment rules out primary or metastatic malignancy in the lungs or pleural space as a significant cause of respiratory insufficiency
- Probability of survival is at least 6 months
Key exclusion criteria (21 listed)
- Presence of do not resuscitate (DNR)/do not intubate (DNI) orders at study entry
- Clinical evidence of left heart failure as the main etiology for respiratory compromise
- Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
- Patients with acute chronic obstructive disease exacerbation as the primary etiology for respiratory failure
- Evidence of accessory respiratory muscle use with breathing
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 |
|---|---|---|
| MethylprednisoloneAlso: Adlone, Caberdelta M, DepMedalone, Depo ModerinIPS cohort only | Drug | Arm A (NIPPV therapy), Arm B (high flow oxygen therapy) |
| Oxygen TherapyAlso: supplemental oxygen therapyReceive high flow oxygen therapy | Procedure or surgery | Arm B (high flow oxygen therapy) |
| Positive Air Pressure DeviceUndergo NIPPV | Device | Arm A (NIPPV therapy) |
Primary outcome
Percent of patients who require intubation or meet criteria for intubation
Time frame: Up to 28 days from study inclusion
Fisher's exact test or a chi-squared test will be used to assess the association between two categorical variables. The intubation rate by 28 days and 95% confidence intervals will be estimated for each treatment arm. Logistic regression will be utilized to assess the effect of patient prognostic factors on the intubation rate by 28 days.
4 secondary outcomes
Time to intubation
Time frame: Up to 28 days
Intensive care unit length of stay
Time frame: Up to 28 days
Hospital length of stay
Time frame: Up to 28 days
Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Time frame: Baseline up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- University of Texas 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.
Nisha Rathi principal investigator
M.D. 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 study testing Methylprednisolone, Oxygen Therapy and Positive Air Pressure Device in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, 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 4 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nisha Rathi, MD (713-792-5040, NRathi@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients who require intubation or meet criteria for intubation (time frame: Up to 28 days from study inclusion). 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 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.