- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206609
The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer
A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To compare the patient preference for inhalational oxygen versus compressed air in the relief of dyspnoea.
- To compare the response to oxygen and air in improvement of dyspnoea in patients with advanced cancer.
- To compare the response to oxygen and air in improvement of dyspnoea in those patients with advanced cancer with documented hypoxia.
- To identify factors other than hypoxia which impact on the sensation of dyspnoea and its relief, when patients are administered oxygen and air.
Hypotheses
- Oxygen improves dyspnoea in patients with cancer more than compressed air.
- Patients with cancer who are hypoxic are more likely than those who are not hypoxic to have improvement of dyspnoea with oxygen administration.
- 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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Victoria
-
Prahran, Victoria, Australia, 3004
- The Alfred Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Patient preference for gas
|
Secondary Outcome Measures
Outcome Measure |
---|
Patient ratings of dyspnoea on visual analogue scales
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer AM Philip, MBBS, The Alfred
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 149/00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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