A study looking at personalised prehabilitation for myeloid leukaemia and myelodysplastic syndrome (PROPEL)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia
Myelodysplastic syndrome (MDS)

Status:

Open

Phase:

Other

This study is assessing the value of prehabilitation for people with acute myeloid leukaemia and myelodysplastic syndrome.

It is open to people who have:

  • acute myeloid leukaemia (AML) with no sign of their leukaemia after initial (induction) chemotherapy
  • AML that has come back and after further treatment there is no sign of their leukaemia
  • myelodysplastic syndrome (MDS) that has excess blast cells

More about this trial

After the initial treatment for AML and for MDS you can have further treatment with more chemotherapy only or chemotherapy followed by a stem cell transplant Open a glossary item. These treatments cause people to:

  • feel very tired (fatigue)
  • feel low in mood
  • have a poor diet
  • feel unable to exercise

These effects can make people stop their treatment. People get the most benefit from treatment if they complete it.

Research in other cancer types shows that a pre treatment plan called prehabilitation can help people complete their course of treatment. It might also improve a person’s quality of life and reduce side effects.

A prehabilitation plan includes:

  • improving diet
  • doing exercise
  • improving people’s moods

A prehabilitation plan is not always available for people with AML or MDS. So it isn’t known whether it is better than the best available practice.

In this study, the team will compare a prehabilitation plan with best available practice. The main aim is to find out whether prehabilitation is better than best available practice in preparing people with AML and MDS for their treatment.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

  • have AML or a type of MDS with excess blasts called MDS-EB2 and you have no sign of disease after having initial treatment with chemotherapy. You can also join if your AML has come back and after further treatment there is no sign of disease.
  • are due to have further treatment with either chemotherapy, a stem cell transplant or both
  • have access to the internet and an email address
  • are willing to use video calls for your appointments and sessions
  • are at least 16 years old

Who can’t take part

You cannot join this study if any of these apply. You:

Trial design

The team need 600 people to take part.

This is a randomised study. A computer puts you into 1 of 2 groups. Neither you nor your doctor choose which group you go into. The 2 groups are:

  • best practice usual care (BPUC)
  • personalised prehabilitation care package (PPCP)

BPUC group
You have a 30 minute appointment with a specialist before you start your chemotherapy. They will tell you where you can find information about:

  • a healthy diet
  • exercise
  • how to look after your emotional wellbeing

PPCP group
You have an hour appointment with a team of specialists before you start chemotherapy. They will work with you to develop a personalised care plan about:

  • a healthy diet
  • exercise
  • how to look after your emotional wellbeing

You see the team of specialists before each chemotherapy treatment and before your stem cell transplant.

You have:

  • a diary to record what you are doing and how you are feeling. You bring this to each session with the specialist team.
  • a weekly phone call from your healthcare team to provide support
  • weekly question and answer group sessions with a dietitian Open a glossary item
  • regular group exercise sessions
  • access to a counsellor therapist and a self help guide to help with your feelings and thoughts

Quality of life
People in both groups fill in questionnaires:

  • when you join the study
  • at regular times during treatment
  • at the end of treatment
  • 3 months after treatment
  • 2 years after treatment

The questions ask about:

  • your general health
  • what you are able to do
  • whether you have seen other health professionals such as your GP

This is a quality of life study questionnaire.

Hospital visits

The study team don’t expect there to be extra visits to the hospital if you take part in the study.

Side effects

Doing exercises might make you feel unwell, tired or breathless. Your muscles might feel sore. These should get better after each exercise session.

We have information about prehabilitation.

Location

Birmingham
Coventry
Doncaster
Liverpool
London
Salisbury

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Janet Dunn
Professor Simon Stanworth

Supported by

NIHR Evaluation Trials and Studies Coordinating Centre (NETSCC)
National Institute of Health and Research: Health Technology Assessment programme
University of Warwick
University Hospitals Coventry and Warwickshire

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19382

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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