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Spots Global Cancer Trial Database for The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer

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Trial Identification

Brief Title: The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer

Official Title: A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer

Study ID: NCT00206609

Conditions

Cancer

Study Description

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.

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. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Alfred Hospital, Prahran, Victoria, Australia

Contact Details

Name: Jennifer AM Philip, MBBS

Affiliation: The Alfred

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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