A study looking at acupuncture and moxibustion to improve well being and quality of life for people with lymphoedema

Please note this trial is no longer recruiting patients.

This study aims to find out if acupuncture and moxibustion can help relieve symptoms for people who have lymphoedema as a result of treatment for either breast cancer or head and neck cancer.

Lymphoedema is swelling caused by a build up of lymph fluid in the body. It mainly affects the arms and legs, causing discomfort, pain and difficulty moving. It sometimes occurs in people who have had cancer treatment such as surgery or radiotherapy. There is no cure for lymphoedema, but there are treatments to relieve symptoms.

Acupuncture and moxibustion are both complementary therapies used in Chinese medicine. Acupuncture uses fine sterile needles which are put just under the skin at particular points (acupuncture points) on the body.

Moxibustion is also sometimes used by acupuncturists. It uses a dried herb called mugwort that is used in many ways. In this study, it is rolled up into a stick. Instead of using needles, the stick is lit and the glowing end is held above acupuncture points to warm them.

We know from earlier studies that acupuncture can improve the quality of life in people with cancer. These researchers want to find out if acupuncture and moxibustion can help lymphoedema treatment to work and improve quality of life.

Recruitment

Start 01/05/2008

End 30/06/2009

Phase

Other

Who can enter

You can enter this trial if

You have lymphoedema after cancer treatment for either breast cancer or head and neck cancer and are under the care of the lymphoedema service at Mount Vernon Hospital
You have been under the care of the lymphoedema service for at least 3 months if you have breast cancer, or at least 2 months if you have head and neck cancer
You have had breast cancer surgery to one breast only, and have mild to moderate uncomplicated lymphoedema (the Lymphoedema Specialist will be able to say if this applies to you)
Have had treatment to try to cure your cancer
Are at least 18 years of age
Are willing to travel to the Lynda Jackson Macmillan Centre at Mount Vernon Hospital to have acupuncture and moxibustion
Are able to speak and understand English

You cannot enter this trial if you

Have any signs of cancer growth
Have had cancer treatment, including surgery, radiotherapy, chemotherapy, or Herceptin in the last 3 months (you can take part if you are having hormone therapy)
Have had acupuncture within the last 6 months

Trial design

This study aims to recruit about 40 people through the lymphoedema service at Mount Vernon Hospital.

First you have 7 treatments, spread over a maximum of 9 weeks. Then the researchers will ask if you would like further treatment. You can have 6 more treatments spread over 8 weeks.

At your first appointment, a researcher will ask you to fill in some questionnaires. The acupuncturist will then ask you questions about your medical history, general physical and emotional health, and lymphoedema symptoms and treatment.

You may have acupuncture on its own, or both acupuncture or moxibustion. The acupuncturist will decide which is most appropriate for you. You will not have acupuncture in the area affected by your lymphoedema. Your first appointment will take about 2 hours as it includes an assessment by the acupuncturist and your first treatment. After that, each treatment will last about 50 to 60 minutes.

You complete more questionnaires before your 7th treatment (and before your 13th treatment if you have further treatment) and again 1 month and 3 months after you have finished treatment. These ask you about your health.

After your treatment has finished you may be asked to take part in discussion groups. These will meet at the Macmillan centre. Each group will have about 4 to 5 people who have had treatment as part of this study. A couple of researchers will also be there. The discussion will be taped and then typed up. It will last about 2 hours.

The researchers will then write a report about the meeting. They will send this back to you to check that it describes correctly what you and the rest of the group said. Some of the comments from the discussion groups may be used as quotes in the report. But all comments are anonymous, it is not possible for anyone to know who said what.

Hospital visits

If you take part in this study, you will need to visit the Macmillan Centre nearly every week while you have acupuncture and moxibustion treatment, and once more if you take part in the discussion groups.

In addition to your visits for this study, you will continue your treatment under the lymphoedema service at the hospital. These appointments will be arranged separately.

Side effects

Acupuncture can have some side effects. Possible side effects include

Drowsiness after treatment
Minor bleeding or bruising in about 3 out of every 100 people (3%)
Pain during treatment in about 1 out of every 100 people (1%)
Symptoms getting worse after treatment in fewer than 3 out of every 100 people (3%) - tell the therapist if this happens to you

There is a small risk that acupuncture may cause infection. This is very unlikely as the therapists in this study are properly trained and follow guidelines by the British Acupuncture Council. Each needle is sterile and used only once.

There is a small risk that moxibustion treatment could cause burns. This is very unlikely when it is carried out by a properly trained practitioner (as in this study).