Condition category
Signs and Symptoms
Date applied
26/11/2014
Date assigned
24/03/2015
Last edited
24/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wang Xiao-Min

ORCID ID

Contact details

No 23
Back Road of Art Gallery
Dong Cheng District
Beijing
100010
China
+86 (0)10 52176900
wangxiaomin_bhtcm@126.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XM201410

Study information

Scientific title

Acupuncture for prevention and treatment of cancer-related fatigue during chemotherapy: a study protocol for a multicenter, randomized, controlled clinical trial

Acronym

Study hypothesis

To assess the therapeutic effect of acupuncture on patients with cancer-related fatigue during chemotherapy.

Ethics approval

Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 27/12/2014, ref: 2014BL-067

Study design

Multicenter randomized controlled interventional clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

Participant 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

Recruitment start date

01/01/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine
No.23, Back Road of Gallery
Beijing
100010
China

Trial participating centre

Beijing ShiJiTan Hospital
10 Tieyi Road Haidian
Beijing
China

Trial participating centre

Beijing Friendship Hospital
36 Yong'an Rd Xicheng
Beijing
China

Sponsor information

Organisation

Beijing Municipal Administration of Hospitals

Sponsor details

No.70
Front Road of Zaolin
Xi Cheng District
Beijing
100032
China
+86 (0)10 83970867
kyc1234@sina.com

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beijing Municipal Administration of Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes