A trial to see whether a dietary supplement can affect abnormal cervical cells (CRISP-1)

This trial is trying to find out if a dietary supplement can help abnormal cervical cells return to normal.

A cervical smear test can pick up different stages of ‘abnormal cells’ on the neck of the womb (the cervix). As these cells are ‘pre cancerous’, the treatment you have can prevent cervical cancer. What you have depends on whether the cells show mild, moderate or severe changes (dyskaryosis).

If you have moderate or severe dyskaryosis, you will then have a colposcopy. This is a close examination of your cervix. If you have mild dyskaryosis you will probably have another smear test 6 months later, or you may have a colposcopy. If you have borderline changes you will have another smear test 6 months later.

A supplement called diindolylmethane (DIM) is found in vegetables such as broccoli, cabbage and cauliflower. Research has shown that DIM may change pre cancerous cells back to normal cells.

In this trial women who have borderline changes or mild dyskaryosis will take a form of DIM called BioResponse DIM every day for 6 months. The aim of this trial is to see if BioResponse DIM helps abnormal cells return to normal.

Please note, women will be invited to take part by the research team in Cardiff. You cannot volunteer for this trial.

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/09/2004

End 31/12/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have had two smear tests in a row that have shown borderline changes, or one that has shown mild dyskaryosis
Are invited to take part

You cannot enter this trial if you

Have been diagnosed with cancer in the last 3 years
Have had treatment for high grade cervical intraepithelial neoplasia (CIN) in the past
Are pregnant, or hoping to be pregnant within the next 6 months
Are breast feeding
Are known to be HIV positive (although you won’t be tested as part of this trial)
Are taking certain drugs such as warfarin, drugs that suppress your immune system, theophylline or drugs for gastric acid reflux or a stomach ulcer

Trial design

This is a randomised trial. It will recruit 850 women into 2 groups. Neither you nor your doctor will be able to decide which group you are in. And neither you nor your doctor will you know which group you are in. This is called a ‘ double blind trial’.

If you are in group 1, you will take two BioResponse DIM capsules once a day, every day for 6 months.

If you are in group 2, you will take two dummy capsules (placebo) once a day, every day for 6 months.

For every 3 women taking part, 2 will be in group 1 and take BioResponse Dim. And 1 will be in group 2 and take a placebo. This is called a 2 to 1 (or 2:1) randomisation.

Hospital visits

If you have had 1 smear test result that showed slight cell changes (mild dyskaryosis) or 2 that have shown borderline changes, you may be invited to take part in this trial. The research team will write to you explaining the trial and asking if you would like to take part. You need to decide whether you would like to take part within 4 weeks of getting the result of your smear test.

You will go to the hospital at the start of the trial. A nurse will take a sample of cells from your cervix using a very small brush. The research team may look at these cells in the lab to help them understand more about abnormal changes and DIM. They may also take a photo of the cervix.

After 3 months you will go back to see the nurse. She will ask you about any side effects you have had, and check that you are taking the capsules every day. They will also take a hair and urine sample.

After 6 months you will have a smear test and a colposcopy. If you were in the group that had a hair and urine sample or photo taken at 3 months, you will have the same again at this visit.

Side effects

Trials so far have shown that BioResponse DIM does not have many side effects. You may feel sick, or have heartburn or wind. But these side effects are not common and are usually mild, and will go away when you stop taking BioResponse DIM.

BioResponse DIM may help relieve pre menstrual symptoms (PMS or PMT).