High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Dyspnea
- Malignant Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 i...
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.
Tracking Information
- NCT #
- NCT02357134
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: David Hui M.D. Anderson Cancer Center