Your session is about to expire
← Back to Search
Methylprednisolone for Blood Cancers
N/A
Recruiting
Led By Nisha Rathi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
Study Summary
This trial will compare the effects of NIPPV and standard high flow oxygen in patients with cancer and respiratory failure.
Who is the study for?
This trial is for cancer patients with respiratory failure who have a certain level of oxygen in their blood, expect to live at least 6 months, and don't have conditions like uncontrolled heart issues or recent surgeries that could complicate treatment. They shouldn't be at risk of vomiting into the lungs or already on non-invasive ventilation.Check my eligibility
What is being tested?
The study tests if non-invasive positive pressure ventilation (NIPPV), which uses a mask to deliver oxygen, is more effective than standard high-flow oxygen therapy through nasal prongs in improving blood oxygen levels and reducing the need for intubation in these patients.See study design
What are the potential side effects?
Possible side effects include discomfort from wearing the mask, skin irritation where the mask touches the face, dryness of mouth or nose from airflow, potential stomach bloating, and rarely lung collapse if air leaks into chest cavity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of patients who require intubation or meet criteria for intubation
Secondary outcome measures
Change in partial pressure of arterial oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Hospital length of stay
Intensive care unit length of stay
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (NIPPV therapy)Experimental Treatment2 Interventions
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.
Group II: Arm B (high flow oxygen therapy)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,061 Total Patients Enrolled
Nisha RathiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a risk of stomach contents getting into your lungs, which can happen if you have a blockage in your esophagus or bowels, or if you are actively vomiting.You have a blockage in your upper airway that doesn't go away.You have experienced a complete stop in your breathing.You have a medical condition called left heart failure that is causing difficulty in breathing.You have injuries to your airway or face that would make it difficult to use a special mask for breathing support.Your chance of living for at least 6 more months is high.You have a recent and severe worsening of your chronic obstructive pulmonary disease (COPD) that is causing respiratory failure.You have difficulty breathing and need to use extra muscles to help you breathe.You have a very low score on the Glasgow Coma Scale or have difficulty protecting your airway.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (high flow oxygen therapy)
- Group 2: Arm A (NIPPV therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger