Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000073505
Ethics application status
Approved
Date submitted
15/02/2006
Date registered
22/02/2006
Date last updated
22/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Methoxyflurane for cancer patients with incident pain receiving radiotherapy
Scientific title
A randomised, open-label, single centre, cross-over study to assess the efficacy and safety of methoxyflurane for the treatment of incident pain in patients undergoing radiotherapy
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incident or movement related pain during transportation to and delivery of radiation therapy 1037 0
Condition category
Condition code
Other 1114 1114 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the intervention/study will last for two days - Day 1 will be either the standard or methoxyflurane arm, and on Day 2 the treatments will cross-over. Methoxyflurane will be self-administered and monitored, and the possible amount inhaled will not exceed Australian Product information guidelines which is 6ml per day, or 15ml per week. The vapour produced from 6ml of an inhaler last about 50 minutes with continuous use. In addition, should they experience unacceptable pain during therapy a standing order is in place to provide a further breakthrough of the medication after 1 hour.
Intervention code [1] 899 0
Treatment: Drugs
Comparator / control treatment
The standard arm reflects current analgesic practice at our institution.. This is usually a 'breakthrough' dose of analgesia given a half an hour prior to the radiotherapy session. The particular analgesia and its dose is determined by the background analgesia that they are receiving. The dose is usually 1/6th to 1/10th of the total 24 hour dose.
Control group
Active

Outcomes
Primary outcome [1] 1484 0
To determine if there is a difference in efficacy between methoxyflurane and standard analgesia in controlling pain associated with movement and positioning of cancer patients during a radiotherapy session.
Timepoint [1] 1484 0
Pain will be measured at several points during the procedure with the primary end-points being 5 minutes before transport to and 5 minutes after completion of, radiotherapy.
Secondary outcome [1] 2672 0
To determine if there is a difference in efficacy between methoxyflurane and standard analgesia in controlling distress associated with movement and positioning of cancer patients during a radiotherapy session.
Timepoint [1] 2672 0
Distress Thermometer will measure the patient's perception of distress 30mins and 5 mins before the radiotherapy and again post radiotherapy. Both groups will be measured similarly.

Eligibility
Key inclusion criteria
Radiotherapy related incident/movement pain; age: ECOG <=2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal imparirment (>2xnormal); previous toxicity or use of methoxyflurane; family or personal history of hyperthermia or sensitivites to flourinated anaesthetics; patients receiving Patient Controlled Analgesia.

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)
Concealment will occur in that the Biostatistics Department will directly inform the Pharmacy Department as to which group the particular patient has been allocated, thus bypassing the clinicians and investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation charts, based on the adaptive biased coin method will be prepared by the Peter MacCallum Centre for Biostatistics & Clinical Trials for the Pharmacy Department. Patients will be randomised to receive either methoxyflurane or standard analgesia on a 1:1 basis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1218 0
Charities/Societies/Foundations
Name [1] 1218 0
Peter MacCallum Cancer Centre
Country [1] 1218 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1076 0
Commercial sector/Industry
Name [1] 1076 0
Medical Development International Limited
Address [1] 1076 0
Country [1] 1076 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Introduction/your consent

You are invited to take part in this research project because you have pain related to cancer that requires radiotherapy. This research project is testing a new way of controlling pain especially during movement. The current standard treatment for movement pain includes morphine which is often not effective. This Participant Information Sheet tells you about the research project. It explains what is involved. This will help you decide if you want to take part in the research.

Please read this Participant Information Sheet carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor.

If you decide you want to take part in the research project, then you will be asked to sign the Consent Form. By signing it you are telling us that you:

· Understand what you have read in the information sheet
· Consent to taking part in the research project
· Consent to the use of your personal and health information as described in the information sheet.

You will be given a copy of this Participant Information Sheet and Consent Form to keep as a record.

Purpose and Background

Doctors are looking for better ways to treat pain caused by movement especially when being transported to and from the radiotherapy department as an inpatient. In this research project, the researchers will test whether giving the medication, methoxyflurane given by inhalation (through a device called a Penthrox Inhaler), is better than the current standard treatment. The standard treatment is an extra dose of morphine, or similar medication, given half an hour before being moved to the radiotherapy department. No study has been done comparing the two treatments.

Methoxyflurane has been approved for use in Australia to relieve acute pain. It is used in many situations including ambulances, emergency departments, dentistry, obstetrics and in children. It provides effective pain relief with very few side effects. Therefore this is not an experimental drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35836 0
Address 35836 0
Country 35836 0
Phone 35836 0
Fax 35836 0
Email 35836 0
Contact person for public queries
Name 10088 0
Dr Odette Spruyt
Address 10088 0
Peter MacCallum Cancer Centre
2 St Andrews Place
East Melbourne VIC 3002
Country 10088 0
Australia
Phone 10088 0
+61 3 96561918
Fax 10088 0
+61 3 96561998
Email 10088 0
Odette.Spruyt@petermac.org
Contact person for scientific queries
Name 1016 0
Dr Simon Wein
Address 1016 0
Peter MacCallum Cancer Centre
2 St Andrews Place
East Melbourne VIC 3002
Country 1016 0
Australia
Phone 1016 0
+61 3 96561918
Fax 1016 0
+61 3 96561998
Email 1016 0
Simon.Wein@petermac.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.