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The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206609
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Peter MacCallum Cancer Centre, Australia
Bethlehem Griffiths Research Foundation
Australian and New Zealand Society of Palliative Medicine
Information provided by:
Bayside Health

Brief Summary:
The purpose of this study is to determine the effect that oxygen has when administered to patients complaining of shortness of breath, where the underlying cause of this symptom is advanced cancer. The study tests the hypothesis that oxygen improves shortness of breath more than air in this population. Both oxygen and air will be administered to patients in random order and in a blinded fashion, with patients asked to rate their shortness of breath before and after each gas. Finally patients will be asked which gas they prefer.

Condition or disease Intervention/treatment Phase
Cancer Procedure: Oxygen and air administration Phase 3

Detailed Description:

Dyspnoea is a devastating symptom in patients with advanced cancer. Management strategies are limited and include behavioural therapies such as relaxation, and pharmacological therapies such as opioids and anxiolytics. The latter are associated with problematic side effects in many patients. Inhalational oxygen is frequently administered but there are few studies in this population which define its role and benefits.

Main Aim: To compare patient preference for inhalational oxygen versus air for relief of dyspnoea.

Specific aims:

  1. To compare the patient preference for inhalational oxygen versus compressed air in the relief of dyspnoea.
  2. To compare the response to oxygen and air in improvement of dyspnoea in patients with advanced cancer.
  3. To compare the response to oxygen and air in improvement of dyspnoea in those patients with advanced cancer with documented hypoxia.
  4. To identify factors other than hypoxia which impact on the sensation of dyspnoea and its relief, when patients are administered oxygen and air.


  1. Oxygen improves dyspnoea in patients with cancer more than compressed air.
  2. Patients with cancer who are hypoxic are more likely than those who are not hypoxic to have improvement of dyspnoea with oxygen administration.
  3. The cause of the dyspnoea may affect whether dyspnoea improves more with oxygen than with air.

Using a randomised, double blind, crossover study design, patients will be adminstered air and oxygen for 15 minutes and be asked to rate dyspnoea scores before and after each gas. Measures of oxygen saturation will be simultaneously measured, and finally the patient preferences for the gases will be sought at trial completion.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
Study Start Date : November 2000
Study Completion Date : March 2005

Primary Outcome Measures :
  1. Patient preference for gas

Secondary Outcome Measures :
  1. Patient ratings of dyspnoea on visual analogue scales

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have dyspnoea mainly due to advanced cancer. Patients with a history of COAD will be eligible for participation in this study as long as the main mechanism of current dyspnoea is related to tumor.
  • intensity of dyspnoea of at least 3 on a 0-10 visual analogue scale at the time of treatment.
  • Regular Bronchodilators and corticosteroids and other adjuvant medications for dyspnoea will be allowed to continue during the study. Inhaled bronchodilator steriods may not be used during the study period.
  • Patients may be receiving regular oral or parenteral opioids and opioid dose must be stable for 24 hours.
  • Patients must have normal cognitive status defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit according to Blessed Orientation Memory & Concentration mental status examination (score<10).
  • Patients must be 18 years of age or older.
  • Patients must have no contraindications to oxygen.
  • Patients must sign written informed consent.

Exclusion Criteria:

  • Patients who have evidence of acute respiratory distress.
  • Patients who are currently oxygen dependent
  • Patients who refuse to participate or are deemed incapable of completing the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206609

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Australia, Victoria
The Alfred Hospital
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Peter MacCallum Cancer Centre, Australia
Bethlehem Griffiths Research Foundation
Australian and New Zealand Society of Palliative Medicine
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Principal Investigator: Jennifer AM Philip, MBBS The Alfred
Layout table for additonal information Identifier: NCT00206609    
Other Study ID Numbers: 149/00
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005
Keywords provided by Bayside Health:
palliative care
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory