Condition category
Cancer
Date applied
09/04/2014
Date assigned
24/04/2014
Last edited
24/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
yumingwei1120@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mingwei Yu

ORCID ID

Contact details

No.23
Back Road of Gallery
Dong Cheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

JJ2011-04

Study information

Scientific title

Efficacy and safety of acupuncture for cancer-related fatigue in patients with breast cancer: a randomized, single-blinded, controlled trial

Acronym

Study hypothesis

To assess the therapeutic effects and safety on acupuncture for cancer-related fatigue in patients with breast cancer.

Ethics approval

Beijing Hospital of Traditional Chinese Medicine Research Ethical Committee, 10/05/2012; ref: 201214

Study design

Randomised single-blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

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 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

Phase

Not Applicable

Drug names

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

10/04/2014

Overall trial end date

10/04/2015

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

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

10/04/2014

Recruitment end date

10/04/2015

Locations

Countries of recruitment

China

Trial participating centre

No.23, Back Road of Gallery
Beijing
100010
China

Sponsor information

Organisation

Beijing Administration of Traditional Chinese Medicine (China)

Sponsor details

No.70
Front Road of Zaolin
Xi Cheng District
Beijing
100053
China

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Beijing Administration of Traditional Chinese Medicine (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes