Condition category
Cancer
Date applied
27/07/2013
Date assigned
14/08/2013
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer-related weakness (fatigue) is a symptom frequently experienced by survivors regardless of the type of cancer or its treatment. Evidence of better ways to manage this is scarce. This purpose of this study is to find out the safety and effectiveness of Traditional Chinese Medicine (TCM) for the management of cancer-related weakness.

Who can participate?
Women with definite diagnosis of breast cancer who feel fatigue or tired can participate in this study.

What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group and the control group. Participants in the intervention group will be treated with TCM granules. Participants in the control group will receive placebo (dummy) granules. 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 and emotion. They will undergo some tests at the start of the study and after treatment in order to find out about the safety. They will be followed up for one month to assess long-term effectiveness.

What are the possible benefits and risks of participating?
All participants will receive free treatment for one month and a series of free examinations. The fatigue could be relieved. The result of this study may help to provide evidence that Traditional Chinese Medicine is safe and effective for managing cancer-related fatigue. Participants have to visit the hospital regularly, which may be inconvenient and disturb their routine. They will have some mild side effects when they start taking TCM granules, such as loss of appetite. That will relieve gradually as they adapt to the smell and taste of TCM.

Where is the study run?
The study is run from three locations in China:
1. Beijing Hospital of Traditional Chinese Medicine
2. Beijing Cancer Hospital
3. People's Hospital of Beijing Daxing District

When is the study starting and how long is it expected to run for?
The study will start in August 2013 and will end in December 2015.

Who is funding the study?
Beijing Municipal Science and Technology Commission, China.

Who is the main contact?
Dr Xiaomin Wang
lichen0701326@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xiaomin Wang

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

D131100002213001

Study information

Scientific title

Traditional Chinese medicine for cancer-related fatigue in patients with breast cancer: a randomized, double-blinded, placebo-controlled trial

Acronym

Study hypothesis

The purpose of this study is to determine whether traditional Chinese medicine is effective in managing cancer-related fatigue.

Ethics approval

Research Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine, 22/04/2013, ref: 201338

Study design

Multicentre randomized double-blinded placebo-controlled study

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 118 eligible participants are randomly assigned to two different groups:
1. Intervention group: Chinese medicine granules (15.75g granules per bag, 2 bags per day) twice a day for one month.
2. Control group: placebo granules (15.75g granules per bag, 2 bags per day) twice a day for one month.
The patients receive assessments fortnightly interval and one month after treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. TCM symptoms scale is a instrument for detecting states of the TCM Symptoms.
2. Revised Piper Fatigue Scale-Chinese Version(RPFS-CV), a multidimensional assessment tool for measuring the level of fatigue subjectively for patients with cancer.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS)
These scales and criteria are used by researchers to assess how a patient's disease is progressing, assess how the disease affects the daily life of the patient.
The outcome measures above will be assessed before the treatment, at 2 and 4 weeks during the treatment, the assessments will be repeated at the end of the first month after the treatment.

Secondary outcome measures

1. Self-Rating Scale of Sleep (SRSS) is a instrument for detecting states of sleeping.
2. The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting states of depression and anxiety.
The outcome measures above will be assessed before the treatment, at 2 and 4 weeks during the treatment, the assessments will be repeated at the end of the first month after the treatment.

Overall trial start date

01/08/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women patients having definite pathologic diagnosis of breast cancer in outpatient
2. Patients who had chemotherapy and /or radiotherapy at least 1 month and mastectomy within 5 years
3. Stage I to III breast cancer with no evidence of recurrence and metastasis
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Traditional Chinese Medicine (TCM) syndrome is differentiated as liver depression and spleen deficiency
6. Anticipated survival time more than six months
7. Patients having no plan to receive chemoradiotherapy during the study
8. patients who are suffering from at least moderate fatigue by Revised Piper Fatigue Scale-Chinese Version(RPFS-CV)
9. All patients who have provided signed informed consent before enrollment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

118

Participant exclusion criteria

1. Patients with serious diseases of heart, liver and kidney, immune and hematopoietic system
2. Children, women who are pregnant
3. Active treatment for anemia with erythropoietin or blood transfusions
4. Patients using steroids to cure cancer-related fatigue
5. Patients having a diagnosis of depression, mental disease and cognitive impairment
6. Patients allergic to Chinese herbal compound

Recruitment start date

01/08/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine

China

Trial participating centre

Beijing Cancer Hospital
China

Trial participating centre

People's Hospital of Beijing Daxing District
China

Sponsor information

Organisation

Beijing Municipal Science and Technology Commission (China)

Sponsor details

No.16 Xizhimen South Street
Xi Cheng District
Beijing
100035
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25927849

Publication citations

Additional files

Editorial Notes