New clinical study: Fatigue in breast cancer survivors - is acupuncture a treatment option?

The study is a multi-center pragmatic randomized, controlled trial with two parallel arms assessing the effectiveness, cost-effectiveness and safety of acupuncture for breast cancer survivors suffering from fatigue. The two arms are: Acupuncture plus usual care and usual care alone. 

The intention is to test acupuncture as a complete treatment package i.e. the overall effect of acupuncture-care, which is highly relevant to breast cancer survivors experiencing CRF. Pragmatic trials also ensure that the sorts of interventions tested can be plausibly rolled out in clinical practice and that the outcomes used to assess effectiveness are valid and easily understood by a range of users, including clinicians, patients, policy makers, and health commissioners. As such, a pragmatic trial will help users to choose between options for care. 

250 women will be randomized into two groups. One group receives 10-12 acupuncture treatments once or twice weekly from an acupuncturist trained with a Bachelor of Acupuncture from Kristiania University College. The acupuncture treatment is free for the participants. The other group (the control group) receives no treatment during the study. Participants in the control group cannot receive acupuncture treatment or other treatments for fatigue during the study period. However, all participants in the study can take their own actions such as exercising, meditating or changing their diet. All measures of this nature will be registered. 

All participants will complete a set of questionnaires at the start of the study, after completion of treatment or after 12 weeks for the control group and after six months. Further, any medical care received during the study period will be documented. This includes life styles advice, and to which point they have followed such advices. All participants will receive written information when the study results are available.

The three-year study will also record changes in quality of life, anxiety and depression, number of hot flashes during day and sleep - all factors researchers believe may affect fatigue.

Who can participate?

We will be recruiting breast cancer survivors who have completed their cancer treatment. Women aged 18 years or older will be eligible for the study. Further, to secure a homogeneous group, participants must be on adjuvant medical treatment with anti-estrogens. 

In order to participate in the study potential participants cannot be using blood-thinning medicine, undergoing treatment for anemia, undergoing palliative care, have been diagnosed with fatigue prior to cancer diagnosis, or are already receiving acupuncture treatment. Further, participants who are pregnant at baseline or planning to get pregnant within the treatment period will be excluded. Potential participants who are unable to understand, speak, or who find it difficult to communicate in Norwegian will be excluded from the study. A sufficient knowledge of Norwegian is necessary for communicating with the acupuncturist and for understanding and filling in all the Norwegian questionnaires within the study. 

Potential and willing participants please contact the Kristiania University College for a screening telephone interview. 

Interested in participating in the study? Contact:

Mona Solberg
Research Coordinator AcuBreast
Kristiania University College, School of Health and Science
mona.solberg@kristiania.no

Do you have any questions about the study? Contact:

Professor Terje Alræk
Project Manager AcuBreast
Kristiania University College, School of Health Science
M +47 478 80 170
terje.alraek@kristiania.no

The AcuBreast study is funded by Rosa sløyfe, a collaboration between The Norwegian Cancer Society (NCS) and Norwegian Breast Cancer Society. 

AcuBreast is a research collaboration between researchers in Kristiania University College, University of Bergen, University of York (England), Korean Institute of Oriental Medicine (Korea), Zakim Center for Integrative Therapies Dana-Farber Cancer Institute (Boston, USA) and Integrative Medicine Service, Memorial Sloan Kettering Cancer Center (New York, USA).