A study looking at different techniques to protect the heart from radiation during radiotherapy for breast cancer (The HeartSpare Study)

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Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This study looked at different ways of holding your breath during radiotherapy for breast cancer and at the position you lay on the radiotherapy couch. 

These techniques may lower the risk of long term side effects to the heart.

This study was open for people to join at different times between February 2012 and October 2014. 

The results of each part were published at different times between 2013 and 2016. 

More about this trial

Having radiotherapy after surgery for breast cancer can help stop the cancer coming back.

Your team takes great care to plan your radiotherapy.  So that the beam reaches as little of the surrounding healthy tissue as possible. This is because radiotherapy can cause side effects months, or even years after treatment. 

Doctors wanted to find ways of lowering the risk of side effects as much as possible. 

This study looked at improving radiotherapy treatment for women with left sided breast cancer, which has a greater risk of long term side effects to the heart. 

Holding your breath when having radiotherapy may reduce the amount of heart tissue exposed to radiation. Breathing in pulls the heart away from the radiotherapy beam.

The team looked at 2 methods. 

For the first women were taught to hold their breath for about 20 seconds while having radiotherapy. 

The 2nd was using a device. The women breathed through the device. When their was held breath at the correct depth the device triggered the radiographer to give the radiotherapy. 

The team also looked at the way women were lying on the table, in particular large breasted women.

Researchers thought that lying on their back (supine) and holding their breath may help to reduce the amount of heart tissue exposed to radiation in these women. They also thought that lying on their front (prone) might be better. 

But doctors didn’t know whether a certain breathing technique, or position, worked best. 

The aim of this study was to find out if one method was better than the others at reducing radiation to the heart tissue. And to see if it was possible to take the best way and do it in other hospitals.

Summary of results

The study team found that:

  • both methods were similar
  • the voluntary breath holding method was preferred by patients and radiographers
  • lying on their back was better than on their front
  • the voluntary breath holding method was safe, possible to do and could be done at other hospitals

About this study
This was a phase 2 study.  

In part 1A for half their course of radiotherapy treatment the women used the voluntary breath holding method. And for the other half of the treatment course they used the device assisted breath holding method. 

In part 1B for half the course of radiotherapy the women were lying face down and breathing normally (free breathing prone treatment). For the other half of their treatment they laid on their backs and used the voluntary breath holding method (supine voluntary breath holding). 

Both parts 1A and 1B were randomised studies. Neither the women or their doctor chose which breathing method was used first.  

23 women were in part 1A of the study. 34 women were part 1B of the study. 

In part 2 everyone used the voluntary breathing method. 101 women joined this part of the study.

Results for part 1A 
In this part the researchers compared the voluntary breath holding method with the device assisted method. They wanted to know:

  • how accurately the location of the treatment area was using both methods
  • if there was a difference in how much healthy tissue was affected
  • how possible it was to do each method
  • how acceptable each method was to patients and radiographers

They found:

  • there was no significant difference between the 2 methods when locating the treatment area 
  • there was no significant difference in the average amount of radiation that the healthy tissue received
  • the patients reported the voluntary breath holding method was easier
  • the radiographers were more satisfied with the voluntary breath holding method
  • there was little difference in the time it took to plan and set up for both methods
  • the average length of treatment time at each session for both methods was 19 minutes

Conclusions for part 1A
The team concluded that the 2 breath holding methods were similar when comparing:

  • locating the treatment area
  • reducing the amount of radiation to healthy tissue

Patients and radiographers preferred the voluntary breath holding method. And it was quicker to do and cheaper than the device assisted method. 

Results for part 1B
In this part the team looked at large breasted women. 

They thought that for these women having radiotherapy lying face down with the affected breast hanging down and breathing normally might be better. This is the free breathing prone treatment. 

The team wanted to compare this way with the voluntary breath holding method while the women were lying on their back (supine). 

The women in this group used the free breathing prone method for half their treatment course. And then for the other half they used the supine voluntary breath holding method.

They found:

  • the supine voluntary breath holding method was statistically significantly Open a glossary item better for the heart than the prone treatment
  • there were more errors when locating the area for treatment with the prone treatment than the supine voluntary breath holding method
  • patients were more satisfied and comfortable with the supine treatment
  • radiographers reported no significant difference in being satisfied with either method
  • there was no difference with the time needed to plan for either method
  • the set up and total time of treatment was much less for the supine voluntary breath holding method

Conclusion for part 1B
The team concluded that for large breasted women the supine voluntary breath holding method was better at reducing the amount of radiation to the heart. 

Radiographers were better able to repeat the radiotherapy treatment more accurately than the free breathing prone treatment method. It was quicker to set up and the treatment sessions were shorter when using the supine method.

Patients found the supine voluntary breath holding method more comfortable. 

Results for part 2
In this stage the researchers wanted to find out if the voluntary breath holding method was safe, possible to do and could be done at other hospitals.

101 women from 10 hospitals around the UK joined this stage of the study. Of these 101 women, the team were able to look at the results of 93 women. 

88 of the 93 women (95%) had a reduced amount of radiation to the heart when compared to what it would have been using the standard free breathing radiotherapy. 

They found that:

  • at each hospital the voluntary breath holding method could be repeated accurately and correctly
  • patients and radiographers accepted the method and were more satisfied with it
  • it took just over 20 minutes for each treatment session

Conclusions for part 2
The team concluded that the voluntary breath holding method:

  • was safe
  • possible to do 
  • could be done in other hospitals

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Dr Anna Kirby

Supported by

NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
NIHR Research for Patient Benefit (RfPB) Programme

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Last review date

CRUK internal database number:

9281

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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