Status:
COMPLETED
Palliative Oxygen for the Relief of Breathlessness
Lead Sponsor:
National Health and Medical Research Council, Australia
Collaborating Sponsors:
Doris Duke Charitable Foundation
Cancer Council Tasmania
Conditions:
Dyspnea
Eligibility:
All Genders
18+ years
Phase:
NA
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 qual...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00327873
Start Date
May 1 2005
End Date
March 1 2008
Last Update
December 14 2009
Active Locations (7)
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1
Duke University Department of Medicine, Division of Medical Oncology
Durham, North Carolina, United States, 27710
2
Sydney Area Health Service, Sydney Cancer Centre
Sydney, New South Wales, Australia, 2050
3
Flinders University, Southern Adelaide Palliative Services
Adelaide, South Australia, Australia, 5041
4
Statewide Palliative Care Service
Launceston, Tasmania, Australia, 7250