Not Yet RecruitingPhase 4ACTRN12606000073505

Methoxyflurane for cancer patients with incident pain receiving radiotherapy

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


Sponsor

Peter MacCallum Cancer Centre

Enrollment

50 participants

Start Date

May 1, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: Methoxyflurane for cancer patients with incident pain receiving radiotherapy. It may be open to adults aged 18 to 75, women who meet certain criteria, including: Radiotherapy related incident/movement pain; age: ECOG <=2. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

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.


Locations(1)

Australia

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ACTRN12606000073505