A study looking at high intensity focal ultrasound for symptoms of women’s cancers (HIFU-Gynae)

Cancer type:

Cervical cancer
Ovarian cancer
Vaginal cancer
Vulval cancer
Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Pilot

This study looked at whether high intensity focused ultrasound (HIFU) is a useful treatment for symptoms of women’s cancer. 

It was for women who had one of the following cancer types that had come back after treatment:

  • cervical cancer
  • vaginal cancer
  • vulval cancer
  • womb cancer 
  • ovarian cancer

The study was open for people to join between 2018 and 2019. The team published results in 2019 and 2021.

More about this trial

Women’s cancers are cancers that start in the female reproductive system. They are also called gynaecological cancer. Common symptoms include pain and bleeding. 

When this trial was done, doctors could treat this with radiotherapy Open a glossary item or chemotherapy Open a glossary item. This isn’t always possible or it doesn’t work. So doctors were looking for other treatments to help with symptoms. 

In this study they looked at HIFU. It uses high frequency sound waves. These waves deliver a strong beam to a specific part of a cancer. This heats and kills the cancer cells.

HIFU researchers were looking at:

  • treating tumours that weren’t cancer. These are called fibroids.
  • whether it could help with pain when cancer had spread to the bone
  • if it could help with symptoms of cancer including pain and bleeding

Everyone in the study had one HIFU treatment guided by an MRI scan. 

The main aims of the study were to find out:

  • if it is safe and possible to give HIFU to this group of women
  • how well MRI guided HIFU helps control symptoms of women’s cancer that have come back
  • more about the side effects

Summary of results

There were 2 parts to this trial:

  • part 1 looked to see if it was safe and possible to treat this group of women with HIFU
  • part 2 looked at how HIFU worked to control symptoms of cancer

Results for part 1
17 women were suitable to have HIFU in part 1. The study team found that it was safe and possible to give HIFU to this group of people.

Results for part 2
11 women were suitable to have HIFU in part 2. Everyone who took part said they had pain before having HIFU. 

The team looked at:

  • how people rated their pain after HIFU. They did this by recording their pain scores
  • if the amount of pain relief they took after HIFU was less

People filled in a diary to record this information from day 7 to day 30 after HIFU. 

The team found that HIFU improved pain and reduced the amount of pain medication that people needed. This was in:

  • 2 out of 5 people with cancer that came back inside the area between the hip bones (pelvis)
  • 3 out of 6 people with cancer that came back outside the pelvis

2 people had vaginal bleeding when they joined the trial. After HIFU:

  • 1 person said the bleeding got a bit better
  • 1 person had no change in the bleeding 

Quality of life
The team looked at how treatment affected quality of life. They found that the women didn’t feel better physically. They said that their mental health improved. This was for everyone who took part, not only those whose symptoms got better. 

Side effects
The most common side effects of HIFU were:

  • skin problems such as a skin rash
  • the cancer pain getting worse for a short period of time 

Conclusion
This was a small study. It showed that it was safe to give HIFU to women whose gynaecological cancer had come back. And it helped to improve symptoms in some women. The team also found the side effects were as expected and were manageable.

The team say it was more difficult to treat areas of cancer that were deep inside the pelvis. This is the area between the hip bones. Pain in these areas is difficult to manage with standard pain control. The team hope that improvements in how HIFU is given can improve this in the future. 

More detailed information
There is more information about this research in the references below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease
G Imseeh and others
International Journal of Hyperthermia, 2021. Volume 38, issue 1, pages 623-632.

MR guided high intensity focused ultrasound (MRgHIFU) for treating recurrent gynaecological tumours: a pilot feasibility study
S Giles and others
British Journal of Radiology, 2091. Volume 92, Issue 1098, pages 1-9. 

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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

Prof Nandita de Souza

Supported by

Cancer Research UK
Institute of Cancer Research
The Royal Marsden NHS Foundation Trust
National Institute of Health Research (NIHR)

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15467

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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