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Could a simple mask help cancer patients avoid a breathing tube?

NCT ID NCT02464696

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tests whether a non-invasive ventilation mask (NIPPV) can reduce the need for intubation in cancer patients with respiratory failure. Researchers will compare NIPPV plus standard oxygen therapy to standard oxygen therapy alone in 256 participants. The goal is to see if the mask improves oxygen levels and reduces shortness of breath, potentially avoiding the risks of a breathing tube.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone (a steroid) and non-invasive positive pressure ventilation (NIPPV) via a mask
What this could lead to
If it works, this could offer a less invasive way to support breathing in cancer patients with respiratory failure, potentially avoiding the need for a breathing tube.
What could go wrong
This is an early-stage trial with 256 participants, so results may not apply to all patients. The intervention may not reduce intubation rates and carries risks like mask discomfort or lung injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2015

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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