NCT00327873

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Typical duration for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 14, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

May 18, 2006

Last Update Submit

December 10, 2009

Conditions

Dyspnea

Keywords

breathlessnessshortness of breathend-of-life carehospice

Outcome Measures

Primary Outcomes (1)

  • Changes in relief from the sensation of breathlessness

    7 days

Secondary Outcomes (4)

  • Changes in quality of life (QOL)

    7 days

  • Identification of patients who benefit from palliative oxygen

    7 days

  • Identification of side effects

    7 days

  • Documentation of costs of palliative oxygen

    7 days

Study Arms (2)

A

EXPERIMENTAL

Oxygen

Other: Oxygen

B

ACTIVE COMPARATOR

Medical Air

Other: Medical Air

Interventions

OxygenOTHER

2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days

A
Medical AirOTHER

2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Duke University Department of Medicine, Division of Medical Oncology

Durham, North Carolina, 27710, United States

Location

Sydney Area Health Service, Sydney Cancer Centre

Sydney, New South Wales, 2050, Australia

Location

Flinders University, Southern Adelaide Palliative Services

Adelaide, South Australia, 5041, Australia

Location

Statewide Palliative Care Service

Launceston, Tasmania, 7250, Australia

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

St Nicholas Hospice

Cambridge, Cambridge, IP33 2QY UK, United Kingdom

Location

Nottingham University

Nottingham, Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 15810762BACKGROUND

  • 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.

    PMID: 14959816BACKGROUND

  • 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.

    PMID: 11083678BACKGROUND

  • 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.

    PMID: 14694916BACKGROUND

  • 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.

    PMID: 20816546DERIVED

Related Links

MeSH Terms

Conditions

Dyspnea

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Amy Abernethy, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • David Curow, BMed,FRACP,MPH

    Flinders University, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

May 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

December 14, 2009

Record last verified: 2009-02

Locations

US(1)GB(2)AU(4)