Recruitment

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