Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）

Study Overview
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Brief Summary
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we plan to conduct this trial to find out： If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy？ How about the extent it relieves？the safety and applicability ？ What's the possible influential factor and mechanism ？

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）

Conditions
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Lung Cancer, Cancer Related Fatigue

Intervention / Treatment
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* Device: acupuncture
* Device: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment; Participants who meet the diagnosis criteria of CRF（ICD-10 criteria); The first time to receive acupuncture treatment; The age is between 18 and 65 years old; Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above; ECOG performance status 0, 1 or 2. Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L. Have not taken any hypnotic, melatonin, or antidepressants within 30 days; Willing to finish the whole observation period; With written consent form signed by themselves. Exclusion Criteria: Participants in other clinical research; Can not be pathologically or cytologically diagnosed as NSCLC; ECOG 3 4; Pregnant woman; >65 or <18 years old; Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue; Patients who have received acupuncture ever before; Received surgery, immunotherapy or target therapy within one month before the recruition； Taking warfarin or heparin, a bleeding tendency exists; Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections； There are cerebral vascular accident history or spinal cord injury history； Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.; Patients with a life expectancy < 3 months; Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture<br>Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks | Device: acupuncture<br>* once per week for 6 weeks，30 mins for each treatment and for seven main acupoints<br>* Other names: Streitberger needles;|
| Sham Comparator: sham acupuncture<br>Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks. | Device: sham acupuncture<br>* the same acupoints and time as in acupuncture arm, but use a Park Sham Device<br>* Other names: Park Sham Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory, BFI |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDASI-C |  | 12 months | 
| number of adverse events of acupuncture |  | 24 months | 
| FACT-L |  | 12 months |