A trial looking at IH636 grape seed extract to reduce side effects of high dose radiotherapy for breast cancer

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial compared grape seed extract (GSPE) to a placebo to see if could help with side effects of radiotherapy. This trial was supported by Cancer Research UK.

Women with breast cancer often have radiotherapy after surgery. This is to reduce the risk of the cancer coming back. In a few women, radiotherapy can cause long term side effects, especially if they have high doses.

The long term side effects include scar tissue (fibrosis) and a collection of fluid (oedema) which can cause the breast tissue to become hard. This can be uncomfortable.  Doctors hope that taking grape seed extract might reduce this hardness, and relieve the discomfort.

The aim of this trial was to see if GSPE could reduce long term side effects of high dose radiotherapy for breast cancer.

Summary of results

This trial was not able to show that grape seed extract capsules reduce breast hardness caused by radiotherapy for breast cancer.

This trial recruited 66 women. Two thirds (44 women) took grape seed extract capsules 3 times a day for 6 months. The other third (22 women) took dummy (placebo) capsules 3 times a day for 6 months.

The research team measured the area of hardness before the women started taking the capsules. And again 6 months after they finished taking the capsules (a year after they started the trial).

A few more women who took grape seed extract had a reduction in breast hardness. But it was not enough of a difference to be ‘significant Open a glossary item’ in statistical terms.

We have based this summary on information from the team who ran the trial. 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. 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

Professor John Yarnold

Supported by

Cancer Research UK

Other information

This is Cancer Research UK trial number CRUK/02/003. 

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 32

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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