ACU.FATIGUE Trial

ACU.FATIGUE is the world’s largest and most advanced clinical trial to investigate whether acupuncture may help women with cope with breast cancer-related fatigue.

The ACU.FATIGUE study is a phase III randomised controlled clinical trial to investigate the effectiveness of acupuncture and self-acupuncture in the management of cancer-related fatigue in breast cancer patients. The study is taking place in the north west of England and in London. In the North West, hospitals involved include the Christie Hospital NHS Foundation Trust in Manchester, North Manchester General Hospital, Oldham Hospital Manchester, Leighton Hospital Crewe and also Beechwood Cancer Care and Blythe House. In London, centres involved include the Royal Marsden NHS Foundation Trust, Guy’s and St Thomas’ and Breast Cancer Haven. 

Over 60% of breast cancer patients use complementary therapies to try to help ease the side effects of their treatment such as fatigue, nausea or hot flushes.  However, little is currently known about how they may work or how safe they are for patients to use alongside conventional treatments like chemotherapy and radiotherapy.

Fatigue is a common and often under-reported problem experienced by breast cancer patients, it can be distressing and negatively impacts on patients’ quality of life. As many as 90% of breast cancer patients receiving chemotherapy may experience considerable fatigue, and as many as 40% of women may also experience moderate to severe levels of fatigue, even several years after treatment has been concluded. Fatigue is one of the most prevalent side effects that can occur after chemotherapy. Currently, there is no proven way to help patients with fatigue and there is a limited evidence base to underpin its management. 

The lack of specific treatments and robust scientific evidence is one of the reasons why further research in areas such as this are needed. And there is some promising preliminary evidence to show that non-pharmacological interventions, such as mild exercise and acupuncture, may help in the management of this complex condition.

The ACU.FATIGUE study will assess the effectiveness of acupuncture in the management of fatigue in breast cancer patients. It will also assess whether self-acupuncture is as effective as therapist-administered acupuncture in maintaining improvements in the longer term.

If you would like more information about this study, or if you or someone you know lives in London or Manchester and would like to be involved, please contact research@breakthrough.org.uk.

Cancer-related fatigue is defined as "a persistent, subjective sense of tiredness related to cancer or cancer treatment that interferes with usual functioning." It is one of the most common and debilitating conditions experienced by patients with cancer. Cancer-related fatigue is characterized by feelings of tiredness, weakness, and lack of energy or concentration, and is distinct from the "normal" drowsiness experienced by healthy individuals in that it is not relieved by rest or sleep. Many patients describe it as feeling "bone tired". It occurs both as a consequence of the cancer itself and as a side effect of cancer treatment and can last for months or years. The precise underlying pathophysiology is largely unknown.

There are a number of other clinical trials available for women with breast cancer. Further information on these other trials, and trials in general, is available through the CancerHelp UK website www.cancerhelp.org.uk

There are now national guidelines produced by the National Institute for Clinical Excellence (NICE) for members of the public. These guidelines can help your doctor assess whether you have or may develop this kind of breast cancer and how to refer for specialist advice if necessary. The guidelines also advise on the need for breast screening depending on your level of risk.