The efficacy and safety of acupuncture in cancer-related fatigue

Not Applicable

Completed

• Conditions: Cancer-related fatigue; Cancer

• Registration Number: ISRCTN71727232
• Lead Sponsor: Beijing Administration of Traditional Chinese Medicine (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-24
• Study Completion: 2015-04-10
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) .<br> 2. Pittsburgh Sleep Quality Index (PSQI)<br> 3. Simplified Nutritional Appetite Questionnaire (SNAQ)<br> 4. The Hospital Anxiety and Depression Scale (HADS)<br> 5. TCM symptoms scale<br> The outcome measures above will be assessed before the treatment, at 2 and 4 weeks during the treatment, and 4 weeks after the treatment.<br>