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

Launched by FUDAN UNIVERSITY · Jun 17, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.