A trial looking at vitamin E and pentoxifylline for radiation fibrosis and lymphoedema after treatment for breast cancer

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial looked at whether vitamin E and pentoxifylline helped to heal tissue damaged by radiotherapy for breast cancer. This trial was supported by Cancer Research UK.

Doctors often treat early breast cancer Open a glossary item with surgery and radiotherapy. Radiotherapy can make tissue less stretchy. This is called radiation fibrosis. It can lead to a swelling of the arm called lymphoedema.

Some research has suggested that it may be possible to treat radiation fibrosis, but results from other trials have been mixed. In this trial, the researchers wanted to find out if vitamin E (alpha-tocopherol) and a drug called pentoxifylline could help to heal tissue damaged by radiotherapy and so improve lymphoedema.

The aim of the trial was to see if having these 2 drugs helped to reduce lymphoedema after radiotherapy for breast cancer.

Summary of results

From their analysis of results, the research team say that vitamin E and pentoxifylline did not improve lymphoedema. They also found that the drugs made no difference to radiation fibrosis in the breast, chest or armpit.

The trial recruited 68 people who had at least a 20% increase in the size of one arm after having radiotherapy for breast cancer. The average length of time since having radiotherapy was 15 and a half years. Three quarters of the people taking part had surgery to remove lymph nodes from under their arm, as well as radiotherapy.

Half the people taking part took vitamin E and pentoxifylline tablets every day for 6 months. The other half took dummy tablets (placebos Open a glossary item).

The research team measured their arm at the beginning of the trial and again after 12 months. They also examined and took photographs of any areas of tissue that had become hard due to radiation fibrosis in the breast, chest or armpit to see if these improved during the trial. They found very little improvement in either lymphoedema or radiation fibrosis in either group.

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/00/001. 

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 182

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

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