Palliative Oxygen for the Relief of Breathlessness

December 10, 2009 updated by: National Health and Medical Research Council, Australia

A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO2>55mmHg

The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When further medical management will not relieve intractable breathlessness, palliative oxygen is often prescribed regardless of whether the person meets the common oxygen funding criteria of severely low blood oxygen levels. The results of this study will inform best practice in the care of people with advanced life-limiting illness and intractable breathlessness, aid in the development of rational funding guidelines, and answer an international debate on the role of palliative oxygen.

This study is a definitive international multi-center randomized double-blind controlled trial of oxygen versus medical air for the relief of breathlessness in participants with intractable dyspnea and PaO2>55mmHg (a measure of blood oxygen levels). Specific aims include demonstration of the effectiveness of oxygen versus medical air in relieving breathlessness in the palliative setting (Specific Aim 1) and improving QOL (Specific Aim 2). Additionally, we will seek to establish which patients derive the greatest benefit (Specific Aim 3), the risks of therapy (Specific Aim 4), and the costs of therapy (Specific Aim 5). The primary hypothesis is that oxygen therapy is superior to air in relieving the sensation of breathlessness for patients with intractable dyspnea due to life-limiting illness in the setting of PaO2>55mmHg.

All participants are enrolled as outpatients. The "eligibility visit" occurs about 5-7 days before starting the study and will include review of the consent form, a short interview, physical exam, and blood tests. The visit can occur in the home or clinic. The blood tests include regular venipuncture and also an arterial blood gas, if these studies have not been done in the preceding month. The "randomization visit" occurs 2 days before the study starts (Day -2) and includes a short interview and quality of life (QOL) questionnaire; this visit is usually done in the home but can also occur in the clinic. The oxygen or air concentrators are delivered to the home on Day 0 by a trained person from the oxygen company. On the same day there is also a brief home visit from the study nurse that includes a short interview and QOL questionnaire. The participant uses the oxygen or medical air gas each of 7 days (Days 0-6) for at least 15 hours each day. While using the oxygen/air the participant fills out a short diary form in the morning and evening, within 30 minutes of waking up or retiring. The diary focuses on the breathlessness, how the participant is feeling, and potential side effects of the gas. The study nurse conducts a "check-in" telephone call on Day 3 to make sure the participant is doing OK. On the last day (Day 6) the nurse visits the home to conduct a brief interview with a short QOL questionnaire. The oxygen company will pick up the concentrator, usually on Day 7.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Sydney Area Health Service, Sydney Cancer Centre
    • South Australia
      • Adelaide, South Australia, Australia, 5041
        • Flinders University, Southern Adelaide Palliative Services
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Statewide Palliative Care Service
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Austin Health
  • United Kingdom
      • Cambridge, United Kingdom, IP33 2QY UK
        • St Nicholas Hospice
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University
  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Department of Medicine, Division of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal illness where the underlying cause has been maximally treated; a medical specialist must document that all identified reversible causes of the dyspnea have been treated; PaO2 measurement must be in the last month
  • Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the Medical Research Council categorical dyspnea exertion scale
  • On stable medications over the prior week except routine "as needed" medications.
  • Survival of at least 1 month in the opinion of the treating physician

Exclusion Criteria:

  • Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e. symptomatic pulmonary hypertension with cor pulmonale
  • Hemoglobin<10.0g/dL as measured within one month of baseline evaluation
  • PaCO2 >50 mm Hg.
  • Confusion as measured by Folstein Mini-mental Status Exam <24/30
  • Current oxygen therapy or continuous oxygen therapy in previous week
  • Actively smoking
  • Active respiratory or cardiac event in the previous 2 weeks, not including upper respiratory tract infections; illness must be resolved for at least 2 weeks prior to baseline evaluation, as judged by a doctor involved in the care of the patient
  • Previous respiratory failure induced by oxygen
  • Unable to give informed consent or complete diary entries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Oxygen
Other: Oxygen
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Active Comparator: B
Medical Air
Other: Medical Air
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in relief from the sensation of breathlessness
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in quality of life (QOL)
Time Frame: 7 days
7 days
Identification of patients who benefit from palliative oxygen
Time Frame: 7 days
7 days
Identification of side effects
Time Frame: 7 days
7 days
Documentation of costs of palliative oxygen
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health and Medical Research Council, Australia

Collaborators

Doris Duke Charitable Foundation
Cancer Council Tasmania
Duke Institute on Care at the End of Life, USA
Flinders Medical Research Institute Small Research Grants Scheme, Australia

Investigators

  • Principal Investigator: David Curow, BMed,FRACP,MPH, Flinders University, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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