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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
AG0064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in relief from the sensation of breathlessness
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Changes in quality of life (QOL)
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Identification of patients who benefit from palliative oxygen
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Identification of side effects
Timepoint [3] 0 0
7 days
Secondary outcome [4] 0 0
Documentation of costs of palliative oxygen
Timepoint [4] 0 0
7 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Sydney Area Health Service, Sydney Cancer Centre - Sydney
Recruitment hospital [2] 0 0
Flinders University, Southern Adelaide Palliative Services - Adelaide
Recruitment hospital [3] 0 0
Statewide Palliative Care Service - Launceston
Recruitment hospital [4] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
5041 - Adelaide
Recruitment postcode(s) [3] 0 0
7250 - Launceston
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Cambridge
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
National Health and Medical Research Council, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Doris Duke Charitable Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Council Tasmania
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Duke Institute on Care at the End of Life, USA
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Flinders Medical Research Institute Small Research Grants Scheme, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00327873
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Amy Abernethy, MD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00327873