Status:
UNKNOWN
Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）
Lead Sponsor:
Fudan University
Conditions:
Lung Cancer
Cancer Related Fatigue
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01881516
Start Date
July 1 2013
Last Update
June 19 2013
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