Effect of acupuncture on patients with cancer-related fatigue during chemotherapy

Completed

Conditions: Cancer-related fatigue
Signs and Symptoms
Malaise and fatigue

Registration Number: ISRCTN10119971

Lead Sponsor: Beijing Municipal Administration of Hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 112

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. TCM symptoms scale to evaluate TCM syndrome (deficiency of spleen qi and stomach qi)<br>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