The efficacy and safety of acupuncture in cancer-related fatigue
| ISRCTN | ISRCTN71727232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71727232 |
| Secondary identifying numbers | JJ2011-04 |
- Submission date
- 09/04/2014
- Registration date
- 24/04/2014
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
yumingwei1120@163.com
Contact information
Scientific
No.23, Back Road of Gallery
Dong Cheng District
Beijing
100010
China
Study information
| Study design | Randomised single-blind controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of acupuncture for cancer-related fatigue in patients with breast cancer: a randomized, single-blinded, controlled trial |
| Study objectives | To assess the therapeutic effects and safety on acupuncture for cancer-related fatigue in patients with breast cancer. |
| Ethics approval(s) | Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 10/05/2012; ref: 201214 |
| Health condition(s) or problem(s) studied | Cancer-related fatigue |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 10/04/2014 |
| Completion date | 10/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/04/2014 |
| Date of final enrolment | 10/04/2015 |
Locations
Countries of recruitment
- China
Study participating centre
100010
China
Sponsor information
Other
No.70, Front Road of Zaolin
Xi Cheng District
Beijing
100053
China
"ROR" |
https://ror.org/003regz62 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/07/2020: No publications found.
