A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
18 Years
N/A
Both
Cancer
Trial Information
A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
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.
Hypotheses
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Patient preference for gas
Principal Investigator
Jennifer AM Philip, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Alfred Hospital
Authority:
Australia: Human Research Ethics Committee
Study ID:
149/00
NCT ID:
NCT00206609
Start Date:
November 2000
Completion Date:
March 2005
Related Keywords:
- Cancer
- Cancer
- palliative care
- dyspnoea
- oxygen
- Dyspnea
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