Cancer Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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