The Role of Oxygen in the Management of Dyspnoea in Advanced Cancer

NCT00206609 | Completed Phase 3

• 1 other identifier: 149/00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; palliative care; dyspnoea; oxygen

Outcome Measures

Primary Outcomes (1)

• Patient preference for gas

Secondary Outcomes (1)

• Patient ratings of dyspnoea on visual analogue scales

Interventions

Oxygen and air administration PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead
• Peter MacCallum Cancer Centre, Australia: collaborator
• Bethlehem Griffiths Research Foundation: collaborator
• Australian and New Zealand Society of Palliative Medicine: collaborator

Study Sites (1)

The Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Neoplasms; Dyspnea

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Jennifer AM Philip, MBBS

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 18, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2000
• Study Completion: March 1, 2005
• Last Updated: September 21, 2005

Record last verified: 2005-09

Locations

AU (1)