CancerPhase 3NCT00206609
The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer
A Phase 3 study testing Oxygen and air administration in people with Cancer, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oxygen and air administration
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2000to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Oxygen and air administration
- Keywords
- Cancer, palliative care, dyspnoea, oxygen
- Medical subject headings
- Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen and air administrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference for gas
Secondary outcomes (1)
Patient ratings of dyspnoea on visual analogue scales
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2000
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Peter MacCallum Cancer Centre, Australia, Bethlehem Griffiths Research Foundation, Australian and New Zealand Society of Palliative Medicine
- Investigators
- Jennifer AM Philip, MBBS, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206609
- Sponsor's protocol ID
- 149/00
- Status last verified
- Sep 2005
- First submitted
- 18 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00206609
- Acronym / sponsor ID
- 149/00
- Conditions
- Cancer
- Keywords
- Cancer, palliative care, dyspnoea, oxygen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Peter MacCallum Cancer Centre, Australia, Bethlehem Griffiths Research Foundation, Australian and New Zealand Society of Palliative Medicine
- Study start
- Nov 2000
- Study completion
- Mar 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen and air administration | Procedure or surgery | – |
Primary outcome
Patient preference for gas
1 secondary outcome
Patient ratings of dyspnoea on visual analogue scales
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer AM Philip, MBBS principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen and air administration in people with Cancer, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preference for gas. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.