Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2005-05-31
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Oxygen
Oxygen
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
B
Medical Air
Medical Air
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Interventions
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Oxygen
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Medical Air
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Doris Duke Charitable Foundation
OTHER
Cancer Council Tasmania
OTHER
Duke Institute on Care at the End of Life, USA
UNKNOWN
Flinders Medical Research Institute Small Research Grants Scheme, Australia
UNKNOWN
National Health and Medical Research Council, Australia
OTHER
Responsible Party
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Duke Cancer Care Research Program, Duke University Medical Center
Principal Investigators
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Amy Abernethy, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
David Curow, BMed,FRACP,MPH
Role: PRINCIPAL_INVESTIGATOR
Flinders University, Australia
Locations
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Duke University Department of Medicine, Division of Medical Oncology
Durham, North Carolina, United States
Sydney Area Health Service, Sydney Cancer Centre
Sydney, New South Wales, Australia
Flinders University, Southern Adelaide Palliative Services
Adelaide, South Australia, Australia
Statewide Palliative Care Service
Launceston, Tasmania, Australia
Austin Health
Melbourne, Victoria, Australia
St Nicholas Hospice
Cambridge, Cambridge, United Kingdom
Nottingham University
Nottingham, Nottingham, United Kingdom
Countries
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References
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Abernethy AP, Currow DC, Frith P, Fazekas B. Prescribing palliative oxygen: a clinician survey of expected benefit and patterns of use. Palliat Med. 2005 Mar;19(2):168-70. doi: 10.1177/026921630501900219. No abstract available.
Booth S, Wade R, Johnson M, Kite S, Swannick M, Anderson H; Expert Working Group of the Scientific Committee of the Association of Palliative Medicine. The use of oxygen in the palliation of breathlessness. A report of the expert working group of the Scientific Committee of the Association of Palliative Medicine. Respir Med. 2004 Jan;98(1):66-77. doi: 10.1016/j.rmed.2003.08.008.
Guyatt GH, McKim DA, Austin P, Bryan R, Norgren J, Weaver B, Goldstein RS. Appropriateness of domiciliary oxygen delivery. Chest. 2000 Nov;118(5):1303-8. doi: 10.1378/chest.118.5.1303.
Bruera E, Sweeney C, Willey J, Palmer JL, Strasser F, Morice RC, Pisters K. A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea. Palliat Med. 2003 Dec;17(8):659-63. doi: 10.1191/0269216303pm826oa.
Abernethy AP, McDonald CF, Frith PA, Clark K, Herndon JE 2nd, Marcello J, Young IH, Bull J, Wilcock A, Booth S, Wheeler JL, Tulsky JA, Crockett AJ, Currow DC. Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial. Lancet. 2010 Sep 4;376(9743):784-93. doi: 10.1016/S0140-6736(10)61115-4.
Related Links
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ISRCTN67448752 on Current Controlled Trials
Other Identifiers
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AG0064
Identifier Type: -
Identifier Source: org_study_id