NCT02357134

High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer

High-Flow Oxygen for Exertional Dyspnea in Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspnea
• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Oxygen Therapy	Receive high-flow oxygen
PROCEDURE	Oxygen Therapy	Receive high-flow air
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Respiratory Therapy	Receive low-flow oxygen
PROCEDURE	Respiratory Therapy	Receive low-flow air

Timeline

• Start date: 2015-03-17
• Primary completion: 2020-12-30
• Completion: 2023-05-31
• First posted: 2015-02-06
• Last updated: 2022-12-07
• Results posted: 2021-06-01

Locations

1 site across 1 country: United States