Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT02357134
Status:
UNKNOWN
Last Update Posted:
2022-12-07
First Post:
2015-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. High-flow oxygen is a device that delivers heated and humidified oxygen through the nose. This may be effective in reducing dyspnea, and may help patients' lungs function better and improve their quality of life.
Detailed Description:
PRIMARY OBJECTIVES:
I. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea).
SECONDARY OBJECTIVES:
I. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.
II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration).
OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later.
ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.
ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.
I. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea).
SECONDARY OBJECTIVES:
I. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.
II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration).
OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later.
ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.
ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: