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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00327873
Registration number
NCT00327873
Ethics application status
Date submitted
18/05/2006
Date registered
19/05/2006
Date last updated
14/12/2009
Titles & IDs
Public title
Palliative Oxygen for the Relief of Breathlessness
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Scientific 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
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Secondary ID [1]
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AG0064
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dyspnea
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Oxygen
Other interventions - Medical Air
Experimental: A - Oxygen
Active Comparator: B - Medical Air
Other interventions: Oxygen
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Other interventions: Medical Air
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Changes in relief from the sensation of breathlessness
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Assessment method [1]
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Timepoint [1]
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7 days
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Secondary outcome [1]
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Changes in quality of life (QOL)
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Assessment method [1]
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Timepoint [1]
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7 days
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Secondary outcome [2]
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Identification of patients who benefit from palliative oxygen
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Assessment method [2]
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Timepoint [2]
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7 days
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Secondary outcome [3]
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Identification of side effects
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Assessment method [3]
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Timepoint [3]
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7 days
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Secondary outcome [4]
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Documentation of costs of palliative oxygen
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Assessment method [4]
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Timepoint [4]
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7 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
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Recruitment hospital [1]
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Sydney Area Health Service, Sydney Cancer Centre - Sydney
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Recruitment hospital [2]
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Flinders University, Southern Adelaide Palliative Services - Adelaide
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Recruitment hospital [3]
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Statewide Palliative Care Service - Launceston
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Recruitment hospital [4]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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5041 - Adelaide
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Recruitment postcode(s) [3]
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7250 - Launceston
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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United Kingdom
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State/province [2]
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Cambridge
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Country [3]
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United Kingdom
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State/province [3]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
National Health and Medical Research Council, Australia
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Doris Duke Charitable Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Cancer Council Tasmania
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Duke Institute on Care at the End of Life, USA
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Flinders Medical Research Institute Small Research Grants Scheme, Australia
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Address [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00327873
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Trial related presentations / publications
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. Erratum In: Respir Med. 2004 May;98(5):476.
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.
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Public notes
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Contacts
Principal investigator
Name
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Amy Abernethy, MD
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Address
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Duke University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00327873
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