Plain English Summary
Background and study aims
Fatigue is the most common symptom experienced by patients with cancer. Fatigue is under-reported and often not screened, partly because of a lack of availability of helpful treatments in the absence of reversible risk factors. The purpose of this study is to assess the therapeutic effects and safety of acupuncture for cancer-related fatigue in patients with breast cancer.
Who can participate?
Women with definite diagnosis of breast cancer who feel tired can participate in this study.
What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group or the control group. Participants in the intervention group will receive acupuncture therapy for 4 weeks. Participants in the control group will receive minimal acupuncture therapy for 4 weeks. They will complete some questionnaires at the start of the study and at fortnightly intervals to find out about any changes in fatigue level, sleep, appetite and emotion. They will be followed up for 1 month to assess long-term effectiveness.
What are the possible benefits and risks of participating?
All participants will receive free treatment for 1 month and a series of free examinations. The fatigue could be relieved. The results of this study may help to provide evidence that acupuncture is effective for managing cancer-related fatigue. The risks of taking part are minimal. Acupuncture is a very safe treatment when given by properly trained clinicians. Occasionally acupuncture can make people feel nauseous or faint or experience a temporary increase in pain either during or after treatment. Participants are warned of these potential side-effects before consenting to have acupuncture.
Where is the study run from?
The study is run from two locations:
1. Beijing Hospital of Traditional Chinese Medicine, China
2. Guang' anmen Hospital, China Academy of Chinese Medical Sciences, China
When is study starting and how long is it expected to run for?
The study will start in April 2014 and will end in April 2015.
Who is funding the study?
Beijing Administration of Traditional Chinese Medicine (China).
Who is the main contact?
Dr Mingwei Yu
Efficacy and safety of acupuncture for cancer-related fatigue in patients with breast cancer: a randomized, single-blinded, controlled trial
To assess the therapeutic effects and safety on acupuncture for cancer-related fatigue in patients with breast cancer.
Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 10/05/2012; ref: 201214
Randomised single-blind controlled study
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
The 40 eligible participants are randomly allocated to two different groups:
1. Participants in the intervention group will receive acupuncture therapy three times a week for 4 weeks
2. Participants in the control group will receive minimal acupuncture therapy three times a week for 4 weeks
All the patients will complete some questionnaires at the start of the study and at fortnightly intervals to find out about any changes in fatigue level, sleep, appetite and emotion. They will be followed up for 1 month to assess long-term effectiveness.
Primary outcome measures
Revised Piper Fatigue Scale-Chinese Version (RPFS-CV), a multidimensional assessment tool for measuring the level of fatigue subjectively for patients with cancer. It will be assessed before the treatment, at 2 and 4 weeks during the treatment, and 4 weeks after the treatment.
Secondary outcome measures
1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) .
2. Pittsburgh Sleep Quality Index (PSQI)
3. Simplified Nutritional Appetite Questionnaire (SNAQ)
4. The Hospital Anxiety and Depression Scale (HADS)
5. TCM symptoms scale
The outcome measures above will be assessed before the treatment, at 2 and 4 weeks during the treatment, and 4 weeks after the treatment.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Women patients with a definite pathologic diagnosis of breast cancer who had complete chemotherapy and/or radiotherapy at least 1 month before and mastectomy within 5 years
2. Stage I-III breast cancer with no evidence of recurrence and metastasis
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Anticipated survival time is more than 6 months
5. Aged 18-65
6. Patients who are suffering from at least moderate fatigue by Revised Piper Fatigue Scale-Chinese Version (RPFS-CV)
7. All patients provided written informed consent before enrollment
Target number of participants
Participant exclusion criteria
1. Complicated with other primary tumors and serious heart, liver, kidney and hematopoietic system diseases
2. Pregnant women or women who are breastfeeding
3. Patients who had needle phobia
4. Patients who had low platelet count or suffered from a bleeding disorder (e.g., haemophilia)
5. Patients who had lymphoedema at the area of the acupuncture points
6. Patients who were on active treatment for anaemia (i.e., EPO or blood transfusions)
7. Patients who were receiving steroids to combat fatigue
8. Patients who had been diagnosed with depression, anxiety disorders, mental illness and cognitive disorders
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
No.23, Back Road of Gallery
Beijing Administration of Traditional Chinese Medicine (China)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting