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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00206609




Registration number
NCT00206609
Ethics application status
Date submitted
18/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005

Titles & IDs
Public title
The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer
Scientific title
A Randomised, Double-Blind Cross-Over Trial of the Effect of Oxygen on Dyspnoea in Patients With Advanced Cancer
Secondary ID [1] 0 0
149/00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Oxygen and air administration

Treatment: Surgery: Oxygen and air administration
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient preference for gas
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Patient ratings of dyspnoea on visual analogue scales
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Bethlehem Griffiths Research Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian and New Zealand Society of Palliative Medicine
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00206609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer AM Philip, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries