Palliative Oxygen for the Relief of Breathlessness
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ClinicalTrials.gov Identifier: NCT00327873 |
Recruitment Status :
Completed
First Posted : May 19, 2006
Last Update Posted : December 14, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyspnea | Other: Oxygen Other: Medical Air | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

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 |
- Changes in relief from the sensation of breathlessness [ Time Frame: 7 days ]
- Changes in quality of life (QOL) [ Time Frame: 7 days ]
- Identification of patients who benefit from palliative oxygen [ Time Frame: 7 days ]
- Identification of side effects [ Time Frame: 7 days ]
- Documentation of costs of palliative oxygen [ Time Frame: 7 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327873
United States, North Carolina | |
Duke University Department of Medicine, Division of Medical Oncology | |
Durham, North Carolina, United States, 27710 | |
Australia, New South Wales | |
Sydney Area Health Service, Sydney Cancer Centre | |
Sydney, New South Wales, Australia, 2050 | |
Australia, South Australia | |
Flinders University, Southern Adelaide Palliative Services | |
Adelaide, South Australia, Australia, 5041 | |
Australia, Tasmania | |
Statewide Palliative Care Service | |
Launceston, Tasmania, Australia, 7250 | |
Australia, Victoria | |
Austin Health | |
Melbourne, Victoria, Australia, 3084 | |
United Kingdom | |
St Nicholas Hospice | |
Cambridge, United Kingdom, IP33 2QY UK | |
Nottingham University | |
Nottingham, United Kingdom, NG5 1PB |
Principal Investigator: | Amy Abernethy, MD | Duke University | |
Principal Investigator: | David Curow, BMed,FRACP,MPH | Flinders University, Australia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amy Abernethy, MD, Assistant Professor of Medicine, Duke Cancer Care Research Program, Duke University Medical Center |
ClinicalTrials.gov Identifier: | NCT00327873 |
Other Study ID Numbers: |
AG0064 |
First Posted: | May 19, 2006 Key Record Dates |
Last Update Posted: | December 14, 2009 |
Last Verified: | February 2009 |
breathlessness shortness of breath end-of-life care hospice |
Dyspnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |