Effect of acupuncture on patients with cancer-related fatigue during chemotherapy
| ISRCTN | ISRCTN10119971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10119971 |
| Secondary identifying numbers | XM201410 |
- Submission date
- 26/11/2014
- Registration date
- 24/03/2015
- Last edited
- 24/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Adverse reaction is a key factor determining whether cancer patients can receive chemotherapy. It is also one of the main reasons for treatment failure. Fatigue is the most common symptom experienced by patients during chemotherapy. Fatigue is under-reported and often not screened for, partly because of a lack of helpful treatments. Many studies have investigated the benefits and success of acupuncture in easing symptoms for fatigue. Thus, the purpose of this study is to assess the effect of acupuncture on patients with cancer-related fatigue during chemotherapy.
Who can participate?
Patients with breast cancer or lung cancer who have at least two cycles of chemotherapy planned during the study program.
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 three times a week for 3 weeks. Participants in the control group will receive shallow needle insertion that does not penetrate below the skin (minimal or superficial needling) at non-acupoints three times a week for 3 weeks. All the participants will complete some questionnaires at the start of the study and at the 3rd day, 7th day, 14th day and 21st day during the chemotherapy to find out about any changes in fatigue level, sleep, appetite and emotion. They will be followed up for a chemotherapy cycle (21 days) to assess long-term effectiveness.
What are the possible benefits and risks of participating?
All participants will receive free acupuncture treatment for nine times 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 during chemotherapy. The risks of taking part are minimal. Acupuncture is a very safe treatment. The acupuncturist has an acupuncture license (Chinese medicine practitioner license) from the Ministry of Health of the People’s Republic of China and takes an educational course to ensure that they strictly follow the study method and are familiar with conducting the study. Occasionally acupuncture can make people feel nauseous or faint, or can cause a temporary increase in pain or a blood clot beneath the skin 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 three locations:
1. Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, China
2. Beijing ShiJiTan Hospital affiliated to Capital Medical University, China
3. Beijing Friendship Hospital affiliated to Capital Medical University, China
When is the study starting and how long is it expected to run for?
From January 2014 to December 2016.
Who is funding the study?
Beijing Municipal Administration of Hospitals (China).
Who is the main contact?
Dr Xiaomin Wang
wangxiaomin_bhtcm@126.com
Contact information
Scientific
No 23
Back Road of Art Gallery
Dong Cheng District
Beijing
100010
China
| Phone | +86 (0)10 52176900 |
|---|---|
| wangxiaomin_bhtcm@126.com |
Study information
| Study design | Multicenter randomized controlled interventional clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Acupuncture for prevention and treatment of cancer-related fatigue during chemotherapy: a study protocol for a multicenter, randomized, controlled clinical trial |
| Study objectives | To assess the therapeutic effect of acupuncture on patients with cancer-related fatigue during chemotherapy. |
| Ethics approval(s) | Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 27/12/2014, ref: 2014BL-067 |
| Health condition(s) or problem(s) studied | Cancer-related fatigue |
| Intervention | The 112 eligible participants are randomly allocated to two different groups: 1. Participants in the intervention group will receive acupuncture therapy three times a week for 3 weeks. 2. Participants in the control group will receive minimal acupuncture therapy (shallow acupuncture at sham points) three times a week for 3 weeks. All the participants will complete some questionnaires at the start of the study and at the 3rd day, 7th day, 14th day and 21st day during the chemotherapy to find out about any changes in fatigue level, sleep, appetite and emotion. They will be followed up for a chemotherapy cycle (21 days) to assess long-term effectiveness. |
| Intervention type | Other |
| Primary outcome measure | Piper Fatigue Scale-Chinese Version (PFS-CV), a multidimensional assessment tool for measuring the level of fatigue subjectively for patients with cancer. It will be assessed before chemotherapy, at the 3rd day, 7th day, 14th day and 21st day during the chemotherapy |
| Secondary outcome measures | 1. TCM symptoms scale to evaluate TCM syndrome (deficiency of spleen qi and stomach qi) 2. TCM (traditional Chinese medicine) syndrome will be assessed before chemotherapy and at the 3rd day, 7th day, 14th day and 21st day during the chemotherapy |
| Overall study start date | 01/01/2014 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 112 |
| Key inclusion criteria | 1. Patients with a definite pathologic diagnosis of breast cancer or lung cancer who had completed chemotherapy and/or radiotherapy at least 3 months, or never received chemotherapy and/or radiotherapy ever before 2. Aged 18-75 3. There are at least two cycles of chemotherapy planned during the study program 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Traditional Chinese Medicine (TCM) syndrome is differentiated as deficiency of spleen qi and stomach qi 6. Anticipated survival time is more than 6 months 7. All patients provided written informed consent before enrollment |
| Key exclusion criteria | 1. Complicated with other serious heart, liver, kidney, immune and hematopoietic system diseases 2. Pregnant women or women who are breastfeeding 3. Patients who were on active treatment for anaemia (i.e., EPO or blood transfusions) 4. Patients who were receiving steroids to alleviate fatigue 5. Patients who had been diagnosed with depression, anxiety disorders, mental illness and cognitive disorders 6. Patients who had low platelet count or suffered from a bleeding disorder (e.g., haemophilia) 7. Complicated with sepsis or bacteremia 8. Patients who had lymphoedema at the area of the acupuncture points 9. Patients who are allergic to stainless steel needle or had needle phobia |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- China
Study participating centres
Beijing
100010
China
Haidian
Beijing
China
Xicheng
Beijing
China
Sponsor information
Government
No.70
Front Road of Zaolin
Xi Cheng District
Beijing
100032
China
| Phone | +86 (0)10 83970867 |
|---|---|
| kyc1234@sina.com | |
"ROR" |
https://ror.org/04baakq55 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
