Traditional Chinese medicine (TCM) for cancer-related fatigue in patients with breast cancer

Not Applicable

Completed

• Conditions: Cancer-related fatigue; Cancer

• Registration Number: ISRCTN12702489
• Lead Sponsor: Beijing Municipal Science and Technology Commission (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 118

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. TCM symptoms scale is a instrument for detecting states of the TCM Symptoms.<br>2. Revised Piper Fatigue Scale-Chinese Version(RPFS-CV), a multidimensional assessment tool for measuring the level of fatigue subjectively for patients with cancer. <br>3. Eastern Cooperative Oncology Group Performance Status (ECOG PS)<br>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.<br>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

Name	Time	Method
1. Self-Rating Scale of Sleep (SRSS) is a instrument for detecting states of sleeping.<br>2. The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting states of depression and anxiety.<br>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.