A trial looking at acupuncture to help fatigue in women who have had treatment for breast cancer

Please note this trial is no longer recruiting patients.

This trial is looking at the use of acupuncture to help women with severe tiredness (fatigue) following chemotherapy treatment for breast cancer.

Research shows that about 40 out of every 100 women (40%) successfully treated for their breast cancer have moderate to severe levels of fatigue. Sometimes it continues for years after treatment has finished. This can have a big impact on your quality of life, causing distress and affecting everyday tasks.

Acupuncture is a type of complementary therapy. It treats certain conditions with fine needles put into the skin at particular points on the body. In this trial you will have either

Acupuncture or
Usual care and education in coping with fatigue (but no acupuncture)

Earlier studies show that both approaches can increase energy levels. But there has been little research into whether they can help with fatigue caused by chemotherapy.

The two groups will be compared to find out which approach is better at helping with fatigue. The trial will also study the benefits of acupuncture carried out by a therapist and by women themselves (self acupuncture).

Recruitment

Start 20/01/2008

End 31/10/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with stage 1, 2, or 3a breast cancer and you finished chemotherapy treatment (with or without any other treatments) between 6 weeks and 5 years ago
Score 5 or above on a fatigue screening scale of 0 to 10, where 0 is no fatigue at all and 10 is extremely fatigued (you will score your fatigue as part of the assessment for this trial)
Had your breast cancer treatment at one of the recruiting hospitals
Are female
Have satisfactory blood test results

You cannot enter this trial if you

Are scared of needles
Are pregnant
Are currently having treatment with chemoradiation
Are taking steroids (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
Are currently having blood transfusions or erythropoietin (EPO) for anaemia
Have any illness which means you cannot have acupuncture as part of this trial

Trial design

This phase 3 trial will recruit about 320 women who have had severe tiredness (fatigue) since finishing chemotherapy for breast cancer. If you had your treatment at one of the recruiting hospitals you may be asked to take part.

There are two different groups in the first part of this trial. It is randomised. This means that women taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have acupuncture. If you are in group 2 you will have your follow up appointments as normal as well as education about fatigue from a nurse. This is called the ‘usual care’ group.

Women in group 1 will have acupuncture carried out by a qualified therapist. You will have a 30 minute session once a week for 6 weeks. During the session, the therapist puts a fine needle into one hand and 2 fine needles into the lower part of one of your legs. He or she will explain everything to you before the session begins.

If you had lymph nodes removed from your armpit during surgery, the therapist will not use the arm on the same side. If you have lymphoedema in either your arms of legs, you will not have acupuncture in these limbs.

If you are in group 2, you will be sent a detailed booklet about how to manage your fatigue at home. This includes suggestions on how to cope with your tiredness and ways to relieve fatigue.

After 6 weeks, women in group 1 will then enter the second part of the trial. There are 3 different groups in this part and it is randomised. A computer will decide whether you have

1 more month of acupuncture with a therapist - Group A
1 month of self acupuncture - Group B
No acupuncture - Group C

If you are in group B, you will be shown how to carry out acupuncture by the therapist.

Whichever group you are in, you will complete a questionnaire at the start of the trial and at the end of treatment (6 weeks later). This includes questions about your quality of life. It will ask you to score your level of fatigue. The research team will also collect information about your breast cancer and treatment from your medical records. If you have acupuncture, you complete the same questionnaire 4 weeks and 8 weeks later.

Hospital visits

If you are in group 1, you will visit hospital for acupuncture once a week for 6 weeks. If you are then in group A, you will go to hospital once a week for a further 4 weeks. If you are in group 2, you will not have any visits to hospital as a result of taking part in this trial.

Side effects

Acupuncture to hands and legs is generally well tolerated therapy. Some people may complain of lightheadedness, or feeling sick when the needles are put in. Some people may feel a small degree of pain when the needles go into the skin, but this is not common. Your arms or legs may also feel numb during the session. These are all temporary effects and disappear when the needles are removed. You may also have some bleeding or bruising at the site of the needles.

If you do not have acupuncture, there are no side effects associated with taking part in this trial.