ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

Condition category

Condition code

Other

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Peter MacCallum Cancer Centre

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Peter MacCallum Cancer Centre

Address

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Medical Development International Limited

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Odette Spruyt

Address

Peter MacCallum Cancer Centre
2 St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

+61 3 96561918

Fax

+61 3 96561998

Odette.Spruyt@petermac.org

Contact person for scientific queries

Name

Dr Simon Wein

Address

Peter MacCallum Cancer Centre
2 St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

+61 3 96561918

Fax

+61 3 96561998

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.

Trial Review

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